Medifit Instruments Limited, the world leading company in the measurement of Cardiac Vagal Tone and non-invasive Brainstem Assessment, announces the successful installation of a second Neuroscope(TM) for gastroenterology research at Hope Hospital, Salford, UK.
The Neuroscope is being successfully used in studies leading to the identification of mechanisms for the future management of pain.
Professor Qasim Aziz and clinical research fellow Dr. Peter Paine were so impressed with the results obtained from the first NeuroScope that a second was soon commissioned. In commenting, Dr. Peter Paine described the information derived from the use of the Neuroscope as being of the highest quality and extremely beneficial and cost effective to our research. He added, It is simply "essential to our work - we are so convinced as to the benefits of the Neuroscope that we are ordering a third device".
Medifit Instruments Limited, based in London at Enfield, UK, manufactures and Markets the Neuroscope(TM), which is the only diagnostic device capable of assessing Cardiac Vagal Tone, non-invasively and in real time. As part of the Central Medical Processor - as a tele-medicine vital signs platform - it is a world leader in the integration and management of patient vital signs and the assessment of brainstem function.
In clinical settings the Central Medical Processor enables the physician to view the patient as a virtual bulletin board of vital signs; the actions and reactions of the brainstem in real time are displayed on a beat by beat (heart beat) basis to provide an instant assessment of how the brain is reacting to any given circumstance.
More information from the company - telephone 079 399 36419 (+44 79 339 36419 if calling from outside the UK)
Empowering Medical Practitioners through improved Diagnostics
Medifit Instruments Limited
Innova Business Centre
Electric Avenue
Enfield
EN3 7XU
ENGLAND
Registered in England, number 3895663
VAT: GB749 4057 07
Phone: +44 (0) 20 8344 8545
Fax: +44 (0) 20 8350 1351
info@medifitinstruments.com
www.medifitinstruments.com
March 7, 2007
Aspirin Saves Lives Of Cancer Patients Suffering Heart Attacks, Despite Fears Of Bleeding
Many cancer patients who have heart attacks often are not treated with life saving aspirin given the belief in the medical community that they could experience lethal bleeding. Researchers at The University of Texas M. D. Anderson Cancer Center, however, say that notion is now proven wrong and that without aspirin, the majority of these patients will die.
Researchers say that their study, to be published in the February 1, 2007 issue of the journal Cancer and now available online, turns common medical assumptions upside down and will likely change medical practice for cancer patients. Because aspirin can thin blood and cancer patients experience low platelet counts and abnormal clotting, physicians view aspirin as a relative contraindication. Given that blood platelets are responsible for the clotting process, physicians do not eagerly prescribe aspirin as a standard treatment.
In this study, however, the investigators found that 9 of 10 cancer patients with thrombocytopenia (low platelet count) who were experiencing a heart attack and who did not receive aspirin died, whereas only one patient died in a group of 17 similar cancer patients who received aspirin. They also found aspirin helps cancer patients with normal platelet count survive heart attacks, just as it does for people without cancer.
"The notion that heart attacks in patients with low platelets should be treated with clot-dissolving aspirin defies logic, that is unless you suspect that the cancer is interfering with platelet function," says the study's senior investigator and author, Jean-Bernard Durand, M.D., assistant professor in the Department of Cardiology at M. D. Anderson Cancer Center.
"We believe tumors may be releasing chemicals that allow the cancer to form new blood supplies which makes blood more susceptible to forming clots." Durand, a heart failure specialist, says. "There appears to be a platelet paradox suggesting that cancer may affect the mechanism of the way that blood clots, and from this analysis, we have found that the single most important predictor of survival in these patients is whether or not they received aspirin." Durand says more research is needed to better understand this contraindication.
According to the World Health Organization there are approximately 10 million cancer patients worldwide, of which 1.5 million may develop blood clots during their cancer treatment and, as such, are at a much higher risk of dying from heart disease if not treated properly. "Now that we have this study, it would be a travesty if you survive treatment for cancer only to die of a heart attack soon thereafter," Durand says.
According to Durand, no guidelines currently exist for treatment of heart attacks in patients with cancer. He says that physicians are especially perplexed about what to do for cancer patients with thrombosis (blood clots), a condition that affects about 15 percent of all cancer patients and can be due to the use of chemotherapy or the presence of cancer.
Durand came to M. D. Anderson in 2000 to start the Cardiomyopathy Services, which is believed to be the only program in the world specifically designed to look at cardiovascular complications caused by chemotherapy treatment. He is also the co-founder of CONQUER (Cardiology Oncology International Quest to Educate and Research Heart Failure in Cancer), a newly created organization with goals of increasing the success of chemotherapy by reducing cardiovascular disease as a barrier and long term risk.
He and anesthesiologist Mona Sarkiss, M.D., Ph.D., made the observation that patients with thrombocytopenia who suffered a heart attack and were being treated in the intensive care unit at M. D. Anderson tended to die more often when they were not given aspirin. However, they noted that some of the patients given aspirin and/or beta-blockers had "great" clinical outcomes. "Because no practice guidelines exist, physicians were treating their patients with great variability and the disparity was obvious," Durand says.
Sarkiss, who is the study's lead author, Durand, and a team of researchers which included investigators from Baylor College of Medicine and Duke University Medical Center, conducted a retrospective analysis of cancer patients treated for heart attacks at M. D. Anderson Cancer Center in 2001. These 70 patients were divided into two groups based on their platelet counts, and data was collected on the use of aspirin, bleeding complications, and survival.
They found that heart attack patients with low platelets who did not receive aspirin had a seven-day survival rate of 6 percent, compared with 90 percent survival in those who received aspirin. Dr. Durand notes that there were no severe bleeding complications in patients who used aspirin. Conversely, patients with low platelet counts who formed a blood clot and were not exposed to aspirin died.
The beneficial effect of aspirin also was seen in patients with normal platelet counts. Seven-day survival was 88 percent in aspirin-treated patients as compared to 45 percent in patients who did not receive aspirin, the researchers found.
Durand observed that these deaths rates are abnormally high. "In the non-cancer patient with acute coronary syndrome anywhere in the United States, an expected seven-day mortality is less than 1 percent," he says.
There were parallel findings for those patients in either group who were treated with beta-blockers, which block the heart's use of adrenalin. The protective effect was not as strong as seen with aspirin, but was still life saving.
In those patients with a normal platelet count, 91 percent survived seven days when treated with beta-blockers, whereas 36 percent survived if they were not treated with the agent. In the thrombocytopenic group, 73 percent survived seven days when treated with beta-blockers, whereas only 13 percent survived if they were not treated.
###
Investigators working with Durand and Sarkiss were: Andrew Shaw, M.D., from Duke; Nasser Lakkis, M.D. from Baylor; and S. Wamique Yusuf, M.D., Carla Warneke, M.D., Gregory Botz, M.D., Cheryl Hirsch-Ginsburg, M.D., J. Chris Champion, M.D., Joseph Swafford, M.D., and Daniel Lenihan, M.D., from M. D. Anderson.
Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center
Researchers say that their study, to be published in the February 1, 2007 issue of the journal Cancer and now available online, turns common medical assumptions upside down and will likely change medical practice for cancer patients. Because aspirin can thin blood and cancer patients experience low platelet counts and abnormal clotting, physicians view aspirin as a relative contraindication. Given that blood platelets are responsible for the clotting process, physicians do not eagerly prescribe aspirin as a standard treatment.
In this study, however, the investigators found that 9 of 10 cancer patients with thrombocytopenia (low platelet count) who were experiencing a heart attack and who did not receive aspirin died, whereas only one patient died in a group of 17 similar cancer patients who received aspirin. They also found aspirin helps cancer patients with normal platelet count survive heart attacks, just as it does for people without cancer.
"The notion that heart attacks in patients with low platelets should be treated with clot-dissolving aspirin defies logic, that is unless you suspect that the cancer is interfering with platelet function," says the study's senior investigator and author, Jean-Bernard Durand, M.D., assistant professor in the Department of Cardiology at M. D. Anderson Cancer Center.
"We believe tumors may be releasing chemicals that allow the cancer to form new blood supplies which makes blood more susceptible to forming clots." Durand, a heart failure specialist, says. "There appears to be a platelet paradox suggesting that cancer may affect the mechanism of the way that blood clots, and from this analysis, we have found that the single most important predictor of survival in these patients is whether or not they received aspirin." Durand says more research is needed to better understand this contraindication.
According to the World Health Organization there are approximately 10 million cancer patients worldwide, of which 1.5 million may develop blood clots during their cancer treatment and, as such, are at a much higher risk of dying from heart disease if not treated properly. "Now that we have this study, it would be a travesty if you survive treatment for cancer only to die of a heart attack soon thereafter," Durand says.
According to Durand, no guidelines currently exist for treatment of heart attacks in patients with cancer. He says that physicians are especially perplexed about what to do for cancer patients with thrombosis (blood clots), a condition that affects about 15 percent of all cancer patients and can be due to the use of chemotherapy or the presence of cancer.
Durand came to M. D. Anderson in 2000 to start the Cardiomyopathy Services, which is believed to be the only program in the world specifically designed to look at cardiovascular complications caused by chemotherapy treatment. He is also the co-founder of CONQUER (Cardiology Oncology International Quest to Educate and Research Heart Failure in Cancer), a newly created organization with goals of increasing the success of chemotherapy by reducing cardiovascular disease as a barrier and long term risk.
He and anesthesiologist Mona Sarkiss, M.D., Ph.D., made the observation that patients with thrombocytopenia who suffered a heart attack and were being treated in the intensive care unit at M. D. Anderson tended to die more often when they were not given aspirin. However, they noted that some of the patients given aspirin and/or beta-blockers had "great" clinical outcomes. "Because no practice guidelines exist, physicians were treating their patients with great variability and the disparity was obvious," Durand says.
Sarkiss, who is the study's lead author, Durand, and a team of researchers which included investigators from Baylor College of Medicine and Duke University Medical Center, conducted a retrospective analysis of cancer patients treated for heart attacks at M. D. Anderson Cancer Center in 2001. These 70 patients were divided into two groups based on their platelet counts, and data was collected on the use of aspirin, bleeding complications, and survival.
They found that heart attack patients with low platelets who did not receive aspirin had a seven-day survival rate of 6 percent, compared with 90 percent survival in those who received aspirin. Dr. Durand notes that there were no severe bleeding complications in patients who used aspirin. Conversely, patients with low platelet counts who formed a blood clot and were not exposed to aspirin died.
The beneficial effect of aspirin also was seen in patients with normal platelet counts. Seven-day survival was 88 percent in aspirin-treated patients as compared to 45 percent in patients who did not receive aspirin, the researchers found.
Durand observed that these deaths rates are abnormally high. "In the non-cancer patient with acute coronary syndrome anywhere in the United States, an expected seven-day mortality is less than 1 percent," he says.
There were parallel findings for those patients in either group who were treated with beta-blockers, which block the heart's use of adrenalin. The protective effect was not as strong as seen with aspirin, but was still life saving.
In those patients with a normal platelet count, 91 percent survived seven days when treated with beta-blockers, whereas 36 percent survived if they were not treated with the agent. In the thrombocytopenic group, 73 percent survived seven days when treated with beta-blockers, whereas only 13 percent survived if they were not treated.
###
Investigators working with Durand and Sarkiss were: Andrew Shaw, M.D., from Duke; Nasser Lakkis, M.D. from Baylor; and S. Wamique Yusuf, M.D., Carla Warneke, M.D., Gregory Botz, M.D., Cheryl Hirsch-Ginsburg, M.D., J. Chris Champion, M.D., Joseph Swafford, M.D., and Daniel Lenihan, M.D., from M. D. Anderson.
Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center
Potential New Pain Therapy Target Revealed By Scripps Research Study
The study was published January 21, 2007 in an advanced online edition of the journal Nature.
The researchers found that TRPA1, a protein that helps transmit pain signals, is a direct sensor of reactive chemicals. "While many noxious and pungent compounds were known to activate this pain receptor, we discovered that they do so by directly and irreversibly binding to the cysteine amino acids of this protein," said Ardem Patapoutian, a Scripps Research scientist whose laboratory conducted the study. "Our study shows that TRPA1 activation is directly linked to chemical insult."
"Cysteines, one of the twenty building blocks of all proteins, are known to undergo oxidation/reduction reactions," Patapoutian continued. "Somehow the TRPA1 protein is tuned to sense cysteine modifications. In fact, any cysteine reactive agent seems to activate TRPA1, although we don't know exactly how cysteine binding translates into ion channel activation."
But this activation mechanism comes with an interesting property.
"Generally, compounds that activate ion channels bind in a lock-and-key mechanism that is readily reversible," said Lindsey Macpherson, another author of the study and a Ph.D. candidate in the Scripps Research Kellogg School of Science and Technology. "The mechanism by which noxious compounds activate TRPA1 is unique. For example, compounds that activate an ion channels through a lock-and-key mechanism have structural similarity. TRPA1 activators have no structural similarity; instead, they share a common potential for chemical reactivity, and their binding is long-lasting."
TRPA1 is not unique among proteins to be activated by cysteine modifying agents, the study noted. Another signaling protein known as Kelch-like ECH-associated protein 1 (KEAP1) is activated by many of the same compounds that activate TRPA1; KEAP1 is a sensor for oxidative damage from free radicals and upregulates expression of antioxidant enzymes. Apparently, reactive compounds can activate at least two pathways through cysteine modification as a warning against cell damage, the study concluded.
"Our findings, which are the result of a successful collaboration with the Ben Cravatt and Peter Schultz labs at Scripps Research, show that modification of reactive cysteines within TRPA1 can cause channel activation," Macpherson said. "Our research efforts are now aimed at further understanding how binding of these compounds activate the channel, and identifying the physiological role of TRPA1 in sensing oxidative stress." The protein is currently being investigated by several pharmaceutical companies as a potential target for chronic pain, Patapoutian noted.
###
Other authors of the study, Noxious Compounds Activate TRPA1 Ion Channels Through Covalent Modification Of Cysteines, are Adrienne E. Dubin, Michael J. Evans, Felix Marr, and Benjamin F. Cravatt of The Scripps Research Institute; and Peter G. Schultz of The Scripps Research Institute and Genomics Institute of the Novartis Research Foundation.
The study was supported by the National Institutes of Health and the Novartis Research Foundation.
About The Scripps Research Institute
The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.
Contact: Keith McKeown
Scripps Research Institute
The researchers found that TRPA1, a protein that helps transmit pain signals, is a direct sensor of reactive chemicals. "While many noxious and pungent compounds were known to activate this pain receptor, we discovered that they do so by directly and irreversibly binding to the cysteine amino acids of this protein," said Ardem Patapoutian, a Scripps Research scientist whose laboratory conducted the study. "Our study shows that TRPA1 activation is directly linked to chemical insult."
"Cysteines, one of the twenty building blocks of all proteins, are known to undergo oxidation/reduction reactions," Patapoutian continued. "Somehow the TRPA1 protein is tuned to sense cysteine modifications. In fact, any cysteine reactive agent seems to activate TRPA1, although we don't know exactly how cysteine binding translates into ion channel activation."
But this activation mechanism comes with an interesting property.
"Generally, compounds that activate ion channels bind in a lock-and-key mechanism that is readily reversible," said Lindsey Macpherson, another author of the study and a Ph.D. candidate in the Scripps Research Kellogg School of Science and Technology. "The mechanism by which noxious compounds activate TRPA1 is unique. For example, compounds that activate an ion channels through a lock-and-key mechanism have structural similarity. TRPA1 activators have no structural similarity; instead, they share a common potential for chemical reactivity, and their binding is long-lasting."
TRPA1 is not unique among proteins to be activated by cysteine modifying agents, the study noted. Another signaling protein known as Kelch-like ECH-associated protein 1 (KEAP1) is activated by many of the same compounds that activate TRPA1; KEAP1 is a sensor for oxidative damage from free radicals and upregulates expression of antioxidant enzymes. Apparently, reactive compounds can activate at least two pathways through cysteine modification as a warning against cell damage, the study concluded.
"Our findings, which are the result of a successful collaboration with the Ben Cravatt and Peter Schultz labs at Scripps Research, show that modification of reactive cysteines within TRPA1 can cause channel activation," Macpherson said. "Our research efforts are now aimed at further understanding how binding of these compounds activate the channel, and identifying the physiological role of TRPA1 in sensing oxidative stress." The protein is currently being investigated by several pharmaceutical companies as a potential target for chronic pain, Patapoutian noted.
###
Other authors of the study, Noxious Compounds Activate TRPA1 Ion Channels Through Covalent Modification Of Cysteines, are Adrienne E. Dubin, Michael J. Evans, Felix Marr, and Benjamin F. Cravatt of The Scripps Research Institute; and Peter G. Schultz of The Scripps Research Institute and Genomics Institute of the Novartis Research Foundation.
The study was supported by the National Institutes of Health and the Novartis Research Foundation.
About The Scripps Research Institute
The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.
Contact: Keith McKeown
Scripps Research Institute
AAGBI Response To The BMJ Medical Milestones Poll Results
The Association of Anaesthetists of Great Britain and Ireland is pleased to note the results of the British Medical Journal Medical Milestones Poll to find the most important medical advance since the BMJ started in 1840.


The most important advance was Sanitation, [clean water and sewage disposal] followed by Antibiotics, and then Anaesthesia in third position, within two percentage points of the winner.


Congratulations to Sanitation, in which John Snow (an anesthetist) was also involved, and the important advance of Antibiotics.


Dr David Whitaker, President of the Association comments, "for Anaesthesia to be ranked in the top three out of an original list of 70 is significant recognition for the importance of the work Anaesthetists do caring for patients through our particular specialty".


Such acknowledgement of Anaesthesia also provides a pleasing start to the Association of Anaesthetists of Great Britain and Ireland's 75th Anniversary Year.


The AAGBI was originally set up in 1932, "to develop Anaesthesia" into what has successfully become the very important specialty further recognized today.


Association of Anaesthetists Anniversary strapline is "75 years, advancing patient safety", which underlines the improvements in patient care and mortality that have continued since the original milestone.
Association of Anaesthetists of Great Britain and Ireland


The most important advance was Sanitation, [clean water and sewage disposal] followed by Antibiotics, and then Anaesthesia in third position, within two percentage points of the winner.


Congratulations to Sanitation, in which John Snow (an anesthetist) was also involved, and the important advance of Antibiotics.


Dr David Whitaker, President of the Association comments, "for Anaesthesia to be ranked in the top three out of an original list of 70 is significant recognition for the importance of the work Anaesthetists do caring for patients through our particular specialty".


Such acknowledgement of Anaesthesia also provides a pleasing start to the Association of Anaesthetists of Great Britain and Ireland's 75th Anniversary Year.


The AAGBI was originally set up in 1932, "to develop Anaesthesia" into what has successfully become the very important specialty further recognized today.


Association of Anaesthetists Anniversary strapline is "75 years, advancing patient safety", which underlines the improvements in patient care and mortality that have continued since the original milestone.
Association of Anaesthetists of Great Britain and Ireland
Scientific, Medical Luminaries Gather At New York Symposium To Discuss The Science Of Electroceuticals
An impressive lineup of medical researchers and clinicians, including Nobel Laureate Louis Ignarro, PhD, gathered at a December 19 symposium in New York City to discuss the new and important scientific discipline of Electroceuticals. В В The next frontier in pulsed electromagnetic field (PEMF) therapy and electrotherapeutics, Electroceuticals are highly-refined electromagnetic fields that are now being used to non-invasively "jumpstart" the body's natural anti-inflammatory response to treat pain successfully and help soft tissue wounds heal faster.В
В Speakers discussed how advances in physics, biology and engineering have all begun to allow medical clinicians to directly affect the electrochemical processes that control all biological processes.В The complete proceedings, which are summarized below, can be accessed at http://www.ivivitechnologies.com.
В В "The science of Electroceuticals is so rich; it is always thrilling to bring such incredible minds together to discuss this exciting field," said Andre DiMino, founder and Co-CEO of Ivivi Technologies, Inc., a company dedicated to the field of electrotherapeutics and sponsor of the symposium.
В DiMino introduced the symposium line-up.В Some key presenters and panelists included:
В Arthur Pilla, PhD., the original developer of bone growth stimulation technology and a leading authority on bioelectromagnetic responses in therapeutic medical applications provided a "state of the science" and discussed the creation and identification of electrotherapeutic signals.В
В Pilla, a professor of biomedical engineering at Columbia University, said that applications for which Electroceuticals are already known to be effective include the healing of recalcitrant bone fractures, increasing the success rate of spinal fusion from 50% to 85%, healing chronic and acute soft tissue wounds, suppressing the body's inflammatory response, increasing local blood circulation, and perhaps most exciting, encouraging angiogenesis.
В Pilla also discussed the practical effects of electrotheraputic technologies вЂ" namely reducing costs of healthcare by reducing surgery and morbidity.В In 1980, bone growth stimulators reduced the cost of health care for delayed union fractures by tenfold. In fact, recent studies have shown Electroceuticals' tremendous promise to significantly reduce healing time, including 59% on surgical wounds, 69% on tendons and 70% on chronic wounds, such as diabetic foot ulcers. В
В Pilla then took attendees across the evolution of the technology to today's Electroceuticals which activate the Calcium(Ca)-Calmodulin(CaM)-Nitric Oxide(NO) pathways that are at the core of the body's healing cascade.
В Louis Ignarro, PhD., who received the 1998 Nobel Prize in Medicine and Physiology for his seminal work on the biological importance of nitric oxide, gave a presentation on the link between Nitric Oxide (NO) and the biological cascade stimulated by the application of Electroceuticals.
В Ignarro, a professor of pharmacology at UCLA, began by discussing the discovery of biological importance of NO, its pharmacological uses, and his discovery that arteries produce NO that maintains the health of the vasculature.В One well-known outcome is the discovery that NO was the neurotransmitter that stimulated male erections, leading to the development of Viagra.В
В Ignarro's research has discovered that NO has a multitude of functions in the body, helping to regulate processes that include angiogenesis, blood pressure control, digestion, respiration and promotion of learning and memory.В NO, found naturally in the human body, is potentially analgesic, anti-oxidant and anti-inflammatory, depending on the biological circumstances.
В Dr. Ignarro described how Ca/CaM activates the enzymes responsible for healthy NO production, the precise binding mechanism triggered by Electroceuticals.В
В Diana Casper, PhD., is a neurobiologist at the Albert Einstein School of Medicine, specializing in neurodegeneration.В She runs the neurosurgery lab at the Montefiore Medical Center. В В
В Casper gave a short history of Parkinson's disease, including pathology and treatments.В She highlighted a 2003 study that determined Parkinson's may be related to inflammation of brain cells, which lasts until death.В Having learned about the effects of pulsed electromagnetic fields, Casper became interested in the possibility that PEMF may help increase neuronal survival in response to inflammation.
В While Casper's research is ongoing, she showed preliminary data which demonstrated the promise of PEMF on neurodegenerative diseases.В Cultures treated with PEMF demonstrated improved neuronal survival.В She also presented data demonstrating decreases in acute inflammation after brain trauma, potentially promising work for problems of inflammation associate with brain trauma.В In a third study, Casper's lab demonstrated that PEMF increases NO levels, which, in turn, has neuroprotective properties.В
В Casper proposed next steps involve animal studies using models of neurodegenerative diseases.В Among the possible neuronal applications for PEMF treatments are Parkinson's, Alzheimer's, Huntington's disease.
В In addition to the keynote speakers, attendees and panelists included several practicing clinicians who described their successful experiences using Electroceuticals to treat patients.В One clinician described his ongoing study of the effect of Electroceuticals on heart disease, based on the known effects of Electroceuticals in improving angiogenesis.
В To access the complete Symposium proceedings please log on to http://www.ivivitechnolgies.com.
В About Ivivi Technologies:
Ivivi Technologies, Inc. (AMEX: II) is a medical technology company focusing on designing, developing and commercializing its proprietary electrotherapeutic technology platform.В Ivivi's research and development activities are focused specifically on pulsed electromagnetic field, or PEMF, technology, which, by creating a therapeutic electrical current in injured soft tissue, stimulates biochemical and physiological healing processes to help repair the injured tissue and reduce related pain and inflammation.В Since the mid-1990's, the Company's Electroceuticals™ have been used for a wide array of conditions, including chronic wounds, pain and edema following plastic and reconstructive surgery and chronic inflammatory disorders.
В Forward-Looking Statements:
This press release contains "forward looking statements" that are subject to risk and uncertainties, including, but not limited to, the Company's limited operating history, history of significant and continued operating losses and substantial accumulated earnings deficit, difficulties with its financial accounting controls, the failure of the market for the Company's products to continue to develop, the inability for customers to receive third party reimbursement, the inability to obtain additional capital, the inability to protect the Company's intellectual property, the loss of any executive officers or key personnel or consultants, competition, changes in the regulatory landscape or the imposition of regulations that affect the Company's products and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's registration statement on Form SB-2.В These risks could cause actual results to differ materially from those expressed in any forward looking statements made by, or on behalf of, the Company.В The Company assumes no obligation to update the information contained in this press release.
В Speakers discussed how advances in physics, biology and engineering have all begun to allow medical clinicians to directly affect the electrochemical processes that control all biological processes.В The complete proceedings, which are summarized below, can be accessed at http://www.ivivitechnologies.com.
В В "The science of Electroceuticals is so rich; it is always thrilling to bring such incredible minds together to discuss this exciting field," said Andre DiMino, founder and Co-CEO of Ivivi Technologies, Inc., a company dedicated to the field of electrotherapeutics and sponsor of the symposium.
В DiMino introduced the symposium line-up.В Some key presenters and panelists included:
В Arthur Pilla, PhD., the original developer of bone growth stimulation technology and a leading authority on bioelectromagnetic responses in therapeutic medical applications provided a "state of the science" and discussed the creation and identification of electrotherapeutic signals.В
В Pilla, a professor of biomedical engineering at Columbia University, said that applications for which Electroceuticals are already known to be effective include the healing of recalcitrant bone fractures, increasing the success rate of spinal fusion from 50% to 85%, healing chronic and acute soft tissue wounds, suppressing the body's inflammatory response, increasing local blood circulation, and perhaps most exciting, encouraging angiogenesis.
В Pilla also discussed the practical effects of electrotheraputic technologies вЂ" namely reducing costs of healthcare by reducing surgery and morbidity.В In 1980, bone growth stimulators reduced the cost of health care for delayed union fractures by tenfold. In fact, recent studies have shown Electroceuticals' tremendous promise to significantly reduce healing time, including 59% on surgical wounds, 69% on tendons and 70% on chronic wounds, such as diabetic foot ulcers. В
В Pilla then took attendees across the evolution of the technology to today's Electroceuticals which activate the Calcium(Ca)-Calmodulin(CaM)-Nitric Oxide(NO) pathways that are at the core of the body's healing cascade.
В Louis Ignarro, PhD., who received the 1998 Nobel Prize in Medicine and Physiology for his seminal work on the biological importance of nitric oxide, gave a presentation on the link between Nitric Oxide (NO) and the biological cascade stimulated by the application of Electroceuticals.
В Ignarro, a professor of pharmacology at UCLA, began by discussing the discovery of biological importance of NO, its pharmacological uses, and his discovery that arteries produce NO that maintains the health of the vasculature.В One well-known outcome is the discovery that NO was the neurotransmitter that stimulated male erections, leading to the development of Viagra.В
В Ignarro's research has discovered that NO has a multitude of functions in the body, helping to regulate processes that include angiogenesis, blood pressure control, digestion, respiration and promotion of learning and memory.В NO, found naturally in the human body, is potentially analgesic, anti-oxidant and anti-inflammatory, depending on the biological circumstances.
В Dr. Ignarro described how Ca/CaM activates the enzymes responsible for healthy NO production, the precise binding mechanism triggered by Electroceuticals.В
В Diana Casper, PhD., is a neurobiologist at the Albert Einstein School of Medicine, specializing in neurodegeneration.В She runs the neurosurgery lab at the Montefiore Medical Center. В В
В Casper gave a short history of Parkinson's disease, including pathology and treatments.В She highlighted a 2003 study that determined Parkinson's may be related to inflammation of brain cells, which lasts until death.В Having learned about the effects of pulsed electromagnetic fields, Casper became interested in the possibility that PEMF may help increase neuronal survival in response to inflammation.
В While Casper's research is ongoing, she showed preliminary data which demonstrated the promise of PEMF on neurodegenerative diseases.В Cultures treated with PEMF demonstrated improved neuronal survival.В She also presented data demonstrating decreases in acute inflammation after brain trauma, potentially promising work for problems of inflammation associate with brain trauma.В In a third study, Casper's lab demonstrated that PEMF increases NO levels, which, in turn, has neuroprotective properties.В
В Casper proposed next steps involve animal studies using models of neurodegenerative diseases.В Among the possible neuronal applications for PEMF treatments are Parkinson's, Alzheimer's, Huntington's disease.
В In addition to the keynote speakers, attendees and panelists included several practicing clinicians who described their successful experiences using Electroceuticals to treat patients.В One clinician described his ongoing study of the effect of Electroceuticals on heart disease, based on the known effects of Electroceuticals in improving angiogenesis.
В To access the complete Symposium proceedings please log on to http://www.ivivitechnolgies.com.
В About Ivivi Technologies:
Ivivi Technologies, Inc. (AMEX: II) is a medical technology company focusing on designing, developing and commercializing its proprietary electrotherapeutic technology platform.В Ivivi's research and development activities are focused specifically on pulsed electromagnetic field, or PEMF, technology, which, by creating a therapeutic electrical current in injured soft tissue, stimulates biochemical and physiological healing processes to help repair the injured tissue and reduce related pain and inflammation.В Since the mid-1990's, the Company's Electroceuticals™ have been used for a wide array of conditions, including chronic wounds, pain and edema following plastic and reconstructive surgery and chronic inflammatory disorders.
В Forward-Looking Statements:
This press release contains "forward looking statements" that are subject to risk and uncertainties, including, but not limited to, the Company's limited operating history, history of significant and continued operating losses and substantial accumulated earnings deficit, difficulties with its financial accounting controls, the failure of the market for the Company's products to continue to develop, the inability for customers to receive third party reimbursement, the inability to obtain additional capital, the inability to protect the Company's intellectual property, the loss of any executive officers or key personnel or consultants, competition, changes in the regulatory landscape or the imposition of regulations that affect the Company's products and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's registration statement on Form SB-2.В These risks could cause actual results to differ materially from those expressed in any forward looking statements made by, or on behalf of, the Company.В The Company assumes no obligation to update the information contained in this press release.
Dental Researchers Test No-Needle Anesthesia, No-Drilling Cavity Care
Imagine having a decayed tooth repaired, painlessly, without drilling or shots of anesthesia to numb the area.
Wishful thinking? Not if two studies being conducted at the University at Buffalo's School of Dental Medicine show positive results.
In one study, funded by a $100,000 grant by Apollonia, LLC, researchers in the school's Center for Dental Studies are testing a nasal spray that numbs the upper teeth.
"If this study is successful," said Sebastian Ciancio, D.D.S., principal investigator on the study, "it may mean the end of dental injections when dentists are performing procedures on the upper arch."
The second study, set to begin in coming months, will test the use of ozone to kill bacteria in a decayed tooth and its potential to eliminate the need for the dreaded drill, at least to repair simple cavities. Researchers at UB and two other U.S. dental schools will conduct the research, which is funded by a $1.5 million grant from Curozone, Inc. and Kavo Dental Manufacturing Co. UB's portion is $400,000.
Ciancio, who also is the UB principal investigator on this study, said the ozone delivery device currently is being used in Europe. "If the U.S. studies are successful, it should be available in this country in about two years," he said.
The nasal spray study is testing the effectiveness in dental procedures of a topical anesthetic normally used by ear, nose and throat physicians when they operate on the nose. Patients who received this anesthetic for that purpose reported it also numbed their upper teeth, sparking interest in using it for dental procedures.
"We currently are testing to determine what the optimal dose is for this spray when used as an anesthetic agent for the maxillary (upper) teeth," said Ciancio. "The current study includes 85 patients and should be completed by the end of January and will be followed by a second study in March. Once we know the results, we'll then test it in a broader population."
Co-investigators, all from the UB dental school, are Eugene Pantera, D.D.S., Sandra Shostad, D.D.S., and Joseph Bonavilla, D.D.S.
The ozone study will evaluate the effectiveness of the ozone delivery device, which fits over a tooth and forms an airtight seal, in arresting tooth decay. The study will enroll 125 participants and will last 18 months.
"Following application of the ozone, patients will use a remineralizing solution, which strengthens the weakened tooth structure and, in many cases, eliminates the need for any dental drilling," said Ciancio.
Additional investigators on this study are Othman Shibly, D.D.S., Jude Fabiano, D.D.S., Benita Sobieroj, D.D.S., Maureen Donley, D.D.S., and Nina Kim, D.D.S., all from the UB dental school faculty.
Contact: Lois Baker
University at Buffalo
Wishful thinking? Not if two studies being conducted at the University at Buffalo's School of Dental Medicine show positive results.
In one study, funded by a $100,000 grant by Apollonia, LLC, researchers in the school's Center for Dental Studies are testing a nasal spray that numbs the upper teeth.
"If this study is successful," said Sebastian Ciancio, D.D.S., principal investigator on the study, "it may mean the end of dental injections when dentists are performing procedures on the upper arch."
The second study, set to begin in coming months, will test the use of ozone to kill bacteria in a decayed tooth and its potential to eliminate the need for the dreaded drill, at least to repair simple cavities. Researchers at UB and two other U.S. dental schools will conduct the research, which is funded by a $1.5 million grant from Curozone, Inc. and Kavo Dental Manufacturing Co. UB's portion is $400,000.
Ciancio, who also is the UB principal investigator on this study, said the ozone delivery device currently is being used in Europe. "If the U.S. studies are successful, it should be available in this country in about two years," he said.
The nasal spray study is testing the effectiveness in dental procedures of a topical anesthetic normally used by ear, nose and throat physicians when they operate on the nose. Patients who received this anesthetic for that purpose reported it also numbed their upper teeth, sparking interest in using it for dental procedures.
"We currently are testing to determine what the optimal dose is for this spray when used as an anesthetic agent for the maxillary (upper) teeth," said Ciancio. "The current study includes 85 patients and should be completed by the end of January and will be followed by a second study in March. Once we know the results, we'll then test it in a broader population."
Co-investigators, all from the UB dental school, are Eugene Pantera, D.D.S., Sandra Shostad, D.D.S., and Joseph Bonavilla, D.D.S.
The ozone study will evaluate the effectiveness of the ozone delivery device, which fits over a tooth and forms an airtight seal, in arresting tooth decay. The study will enroll 125 participants and will last 18 months.
"Following application of the ozone, patients will use a remineralizing solution, which strengthens the weakened tooth structure and, in many cases, eliminates the need for any dental drilling," said Ciancio.
Additional investigators on this study are Othman Shibly, D.D.S., Jude Fabiano, D.D.S., Benita Sobieroj, D.D.S., Maureen Donley, D.D.S., and Nina Kim, D.D.S., all from the UB dental school faculty.
Contact: Lois Baker
University at Buffalo
Low-Dose Steroids Reduce Joint Damage From Rheumatoid Arthritis
Low doses of steroids can inhibit joint damage when used in the early phase of rheumatoid arthritis, according to a new review of evidence.
High-quality evidence supports combining the pills with standard medications in the first two years after diagnosis. "Such treatment should be made readily available to patients," say review authors led by John Kirwan of Liverpool Women's Hospital in England.
Concern exists about the side effects of steroid therapy, however. High doses can contribute to heart disease, osteoporosis and other complications. Questions remain about whether smaller doses lead to similar problems.
Rheumatoid arthritis is a chronic disease in which the body's immune system attacks and destroys healthy joint tissue. The hands and feet are frequently affected, and as the disease progresses it can cause pain, swelling, deformity and disability.
The steroids studied in the review are known as glucocorticoids and include the well-known anti-inflammatory prednisone. This medication is often prescribed in the first few months after diagnosis to relieve the discomfort of RA until slower-acting drugs begin protecting the joints.
Until now, concerns about side effects caused most rheumatologists to "put people on the lowest possible dose of steroids and get them off it as soon as possible," said Scott Zashin, M.D., of the University of Texas Southwestern Medical Center. "Now, we have to give steroids a little more respect."
The review appears in the most recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The systematic review is based on 15 studies including 1,414 patients. In most of the studies, patients received low doses of glucocorticoid pills along with so-called disease-modifying drugs for one to two years. Periodic X-rays revealed the extent of joint erosion and other signs of damage.
All studies except one showed reduced progression of joint damage in patients taking glucocorticoids. When reviewers used statistical methods to focus on only the highest-quality data, the benefits remained statistically significant.
"Even in the most conservative estimate, the evidence that glucocorticoids given in addition to standard therapy can substantially reduce the rate of erosion progression in rheumatoid arthritis is convincing," they say.
The authors say, however, that minimization of joint damage seen on X-rays may not equate to noticeable improvements for patients: "It does not necessarily follow that patients will gain long-term functional benefit." However, two related studies, including one by Kirwan, suggest "an important link" between the two.
Because of the known health risks associated with intensive steroid use, concern persists regarding long-term use at any level. The authors cite a 2006 systematic review covering the adverse effects of low-dose glucocorticoids, which concluded that "few of the commonly held beliefs about their incidence, prevalence and impact are supported by clear scientific evidence."
Moreover, safety data from recent randomized controlled clinical trials of low-dose steroids for RA suggest that negative side effects are "modest" and similar to those of sham treatments, say Kirwan and colleagues. Additionally, the most immediate concern -- reduced bone mineral density -- can now be readily treated.
Nevertheless, potential adverse reactions to glucocorticoid therapy merit further research, say the authors, as does usefulness of steroid treatment for patients who have had rheumatoid arthritis for 3 years or more.
Zashin urges patients recently diagnosed with rheumatoid arthritis to see a rheumatologist without delay. Early and aggressive treatment can prevent severe joint damage and disability for most people, he says.
###
Kirwan JR, et al. Effects of glucocorticoids on radiological progression in rheumatoid arthritis (Review). Cochrane Database of Systematic Reviews 2007, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.
Contact: Lisa Esposito
Center for the Advancement of Health
High-quality evidence supports combining the pills with standard medications in the first two years after diagnosis. "Such treatment should be made readily available to patients," say review authors led by John Kirwan of Liverpool Women's Hospital in England.
Concern exists about the side effects of steroid therapy, however. High doses can contribute to heart disease, osteoporosis and other complications. Questions remain about whether smaller doses lead to similar problems.
Rheumatoid arthritis is a chronic disease in which the body's immune system attacks and destroys healthy joint tissue. The hands and feet are frequently affected, and as the disease progresses it can cause pain, swelling, deformity and disability.
The steroids studied in the review are known as glucocorticoids and include the well-known anti-inflammatory prednisone. This medication is often prescribed in the first few months after diagnosis to relieve the discomfort of RA until slower-acting drugs begin protecting the joints.
Until now, concerns about side effects caused most rheumatologists to "put people on the lowest possible dose of steroids and get them off it as soon as possible," said Scott Zashin, M.D., of the University of Texas Southwestern Medical Center. "Now, we have to give steroids a little more respect."
The review appears in the most recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The systematic review is based on 15 studies including 1,414 patients. In most of the studies, patients received low doses of glucocorticoid pills along with so-called disease-modifying drugs for one to two years. Periodic X-rays revealed the extent of joint erosion and other signs of damage.
All studies except one showed reduced progression of joint damage in patients taking glucocorticoids. When reviewers used statistical methods to focus on only the highest-quality data, the benefits remained statistically significant.
"Even in the most conservative estimate, the evidence that glucocorticoids given in addition to standard therapy can substantially reduce the rate of erosion progression in rheumatoid arthritis is convincing," they say.
The authors say, however, that minimization of joint damage seen on X-rays may not equate to noticeable improvements for patients: "It does not necessarily follow that patients will gain long-term functional benefit." However, two related studies, including one by Kirwan, suggest "an important link" between the two.
Because of the known health risks associated with intensive steroid use, concern persists regarding long-term use at any level. The authors cite a 2006 systematic review covering the adverse effects of low-dose glucocorticoids, which concluded that "few of the commonly held beliefs about their incidence, prevalence and impact are supported by clear scientific evidence."
Moreover, safety data from recent randomized controlled clinical trials of low-dose steroids for RA suggest that negative side effects are "modest" and similar to those of sham treatments, say Kirwan and colleagues. Additionally, the most immediate concern -- reduced bone mineral density -- can now be readily treated.
Nevertheless, potential adverse reactions to glucocorticoid therapy merit further research, say the authors, as does usefulness of steroid treatment for patients who have had rheumatoid arthritis for 3 years or more.
Zashin urges patients recently diagnosed with rheumatoid arthritis to see a rheumatologist without delay. Early and aggressive treatment can prevent severe joint damage and disability for most people, he says.
###
Kirwan JR, et al. Effects of glucocorticoids on radiological progression in rheumatoid arthritis (Review). Cochrane Database of Systematic Reviews 2007, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.
Contact: Lisa Esposito
Center for the Advancement of Health
2 Minutes Conversation prevents RX - Wrong-Site Surgery
A study of Johns Hopkins surgeons, anesthesiologists and nurses suggests that hospital policies requiring a brief preoperation "team meeting" to make sure surgery is performed on the right patient and the right part of the body could decrease errors.
In the study, which will appear in the February issue of the Journal of the American College of Surgeons, Hopkins OR personnel were "very positive" about the briefings, according to surgeon Martin Makary, M.D., M.P.H., director of the Johns Hopkins Center for Surgical Outcomes Research and lead author of the study.
"Although we lack systems for uniform reporting of wrong-site surgeries to understand the extent of the problem, we observed team meetings increase the awareness of OR personnel with regard to the site and procedure and their perceptions of operating rooms safety" says Makary. He stressed that wrong-site surgery is exceptionally rare but entirely preventable.
A study published last year in the Archives of Surgery that looked at 2.8 million operations in Massachusetts over a 20-year period suggests that the rate of "wrong-site" surgery anywhere other than the spine is 1 in every 112,994 operations. The study excluded the spine because researchers defined wrong-site surgeries as operations conducted on a different organ or body part than intended by the surgeon and patient. Since the spine is one body part, even though a surgeon may have operated on the wrong part of the spine, technically it is still the right part of the body.
The Joint Commission, which evaluates and accredits nearly 15,000 health care organizations and programs in the United States, requires hospitals to have a presurgical conversation in the OR before every surgery.
Although Makary says no national standard was set by the Joint Commission, he and others led efforts at Hopkins to enforce the mandate, developing a standardized OR briefing program that became Hopkins Hospital policy in June 2006. Since then, he has collaborated with Rochester University, Yale, Columbia and Cornell and the World Health Organization to broaden the use and reach of the Hopkins program.
The briefing consists of a two-minute meeting during which all members of the OR team state their name and role, and the lead surgeon identifies and verifies such critical components of the operation as the patient's identity, the surgical site and other patient safety concerns. The briefing is performed after anesthesia is administered and prior to incision.
A survey, among 147 surgeons, 59 anesthesiologists, 187 nurses and 29 other OR staff, was given twice - before implementing the policy and after it had been in effect for three-months.
After training, a 13.2 percent increase in those who believed the policy would be effective was recorded among the OR personnel. And more than 90 percent agreed that "a team discussion before a surgical procedure is important for patient safety."
"The Joint Commission identified communication breakdowns as the most common root cause of wrong-site surgeries," says Makary. "Our research indicates that OR personnel see presurgical briefings as a useful tool to help prevent such errors."
Before the new policy was implemented, Makary notes, many surgeons would walk into the OR and start working without a conversation of any kind and without even knowing the names of the nurses and other staff who were assisting them.
###
The survey is based on a similar questionnaire designed by the airline industry to assess programs designed to reduce safety errors.
Hopkins faculty members Peter J. Pronovost, M.D., Ph.D., and Bryan Sexton, Ph.D., also contributed to the article.
Contact: Eric Vohr
Johns Hopkins Medical Institutions
In the study, which will appear in the February issue of the Journal of the American College of Surgeons, Hopkins OR personnel were "very positive" about the briefings, according to surgeon Martin Makary, M.D., M.P.H., director of the Johns Hopkins Center for Surgical Outcomes Research and lead author of the study.
"Although we lack systems for uniform reporting of wrong-site surgeries to understand the extent of the problem, we observed team meetings increase the awareness of OR personnel with regard to the site and procedure and their perceptions of operating rooms safety" says Makary. He stressed that wrong-site surgery is exceptionally rare but entirely preventable.
A study published last year in the Archives of Surgery that looked at 2.8 million operations in Massachusetts over a 20-year period suggests that the rate of "wrong-site" surgery anywhere other than the spine is 1 in every 112,994 operations. The study excluded the spine because researchers defined wrong-site surgeries as operations conducted on a different organ or body part than intended by the surgeon and patient. Since the spine is one body part, even though a surgeon may have operated on the wrong part of the spine, technically it is still the right part of the body.
The Joint Commission, which evaluates and accredits nearly 15,000 health care organizations and programs in the United States, requires hospitals to have a presurgical conversation in the OR before every surgery.
Although Makary says no national standard was set by the Joint Commission, he and others led efforts at Hopkins to enforce the mandate, developing a standardized OR briefing program that became Hopkins Hospital policy in June 2006. Since then, he has collaborated with Rochester University, Yale, Columbia and Cornell and the World Health Organization to broaden the use and reach of the Hopkins program.
The briefing consists of a two-minute meeting during which all members of the OR team state their name and role, and the lead surgeon identifies and verifies such critical components of the operation as the patient's identity, the surgical site and other patient safety concerns. The briefing is performed after anesthesia is administered and prior to incision.
A survey, among 147 surgeons, 59 anesthesiologists, 187 nurses and 29 other OR staff, was given twice - before implementing the policy and after it had been in effect for three-months.
After training, a 13.2 percent increase in those who believed the policy would be effective was recorded among the OR personnel. And more than 90 percent agreed that "a team discussion before a surgical procedure is important for patient safety."
"The Joint Commission identified communication breakdowns as the most common root cause of wrong-site surgeries," says Makary. "Our research indicates that OR personnel see presurgical briefings as a useful tool to help prevent such errors."
Before the new policy was implemented, Makary notes, many surgeons would walk into the OR and start working without a conversation of any kind and without even knowing the names of the nurses and other staff who were assisting them.
###
The survey is based on a similar questionnaire designed by the airline industry to assess programs designed to reduce safety errors.
Hopkins faculty members Peter J. Pronovost, M.D., Ph.D., and Bryan Sexton, Ph.D., also contributed to the article.
Contact: Eric Vohr
Johns Hopkins Medical Institutions
Back Pain: When To Opt For Surgery, From The Harvard Health Letter
Low back pain is an extremely common condition: 80% of Americans experience at least one bout of it some time during their lives. Usually, rest, some pain relievers, and perhaps some exercises help it go away. But for many millions, the pain lingers and may become severe and debilitating. How do you know when back pain warrants surgery? The February 2007 issue of the Harvard Health Letter investigates.
Deciding to have surgery is never simple, but it's especially difficult when the back is involved. Many studies of back surgery have been small. Popular procedures have been questioned, and new ones get introduced before we really know how well they'll work over the long haul. It's hard enough for doctors to figure out what to do about surgery for back pain. Patients are often even more confused.
Back surgery is an option for people with long-lasting pain due to herniated disks, spinal stenosis, or degenerative disease. Studies have shown good results from spinal stenosis surgery, with any lingering pain controlled with medication. On the other hand, doctors are beginning to question whether too many surgeries are performed to treat degenerative disease. As for herniated disks, a recent study found that surgical and nonsurgical treatments worked equally well. An editorial accompanying the study said toss-up results show that the decision whether to have surgery is a matter of patient preference more than anything else.
Ideally, your primary care physician can walk you through your options- surgical and non-to get you to an effective treatment.
Harvard Health Publications
http://www.health.harvard.edu/health
Deciding to have surgery is never simple, but it's especially difficult when the back is involved. Many studies of back surgery have been small. Popular procedures have been questioned, and new ones get introduced before we really know how well they'll work over the long haul. It's hard enough for doctors to figure out what to do about surgery for back pain. Patients are often even more confused.
Back surgery is an option for people with long-lasting pain due to herniated disks, spinal stenosis, or degenerative disease. Studies have shown good results from spinal stenosis surgery, with any lingering pain controlled with medication. On the other hand, doctors are beginning to question whether too many surgeries are performed to treat degenerative disease. As for herniated disks, a recent study found that surgical and nonsurgical treatments worked equally well. An editorial accompanying the study said toss-up results show that the decision whether to have surgery is a matter of patient preference more than anything else.
Ideally, your primary care physician can walk you through your options- surgical and non-to get you to an effective treatment.
Harvard Health Publications
http://www.health.harvard.edu/health
Surgical Trauma In Back Surgery Lowered By Pretreating Spinal Cord With Local Anesthetic
Texas researchers believe that they have discovered how to prevent many cases of the most common problem encountered by patients undergoing spine surgery: failed back surgery syndrome (FBSS).
FBSS occurs when surgery either fails to cure back pain or leads to additional chronic pain after a spinal operation.
In experiments using laboratory rats, neuroscientists at the University of Texas Medical Branch at Galveston (UTMB) applied the local anesthetic Lidocaine to the animals' exposed spinal cords before subjecting the rats to simulated spinal surgery. They found the procedure prevented both the release of chemicals associated with FBSS and behavior typical of animals experiencing FBSS-caused pain.
A paper describing their investigation is in press at the journal Experimental Neurology, and will be available January 26 at the journal's Web site in the "Articles in Press" section.
"Our hypothesis is that the unintentional stretching and compression that can occur in the spinal cord during surgery causes the release of large quantities of chemicals called excitatory amino acids, which produce a toxic environment in the spine and cause long-term hyperexcitability in spinal neurons, generating chronic neuropathic pain - pain produced in the nerves themselves," said UTMB neuroscience and cell biology professor Claire Hulsebosch, a senior author of the paper along with UTMB neuroscience and cell biology professor David J. McAdoo. "When we applied Lidocaine to the surface of the spinal cord before conducting our surgery," Hulsebosch continued, "we found that those releases were completely blocked."
In addition, Hulsebosch noted, rats whose spines had been pretreated with the local anesthetic showed less sensitivity and scored much lower than non-treated rats on a standard test for symptoms of neuropathic pain. In the test, steadily increasing pressure is applied to a rat's hind paws with fishing-line-like filaments. Rats experiencing the hypersensitivity associated with chronic pain tend to withdraw their paws at very low pressures, while those without chronic nerve pain react only to much higher pressures.
Researchers involved in the experiment cautioned that FBSS is a somewhat loose diagnosis, one with multiple causes that also may include pre-existing conditions that spinal surgery does not successfully address. "It also has to be said that the model we used, in which we cut the nerves in the dorsal root on the surface of the spinal cord, involved a severe injury," said UTMB neuroscience graduate student and first author Brian Rooney "But we think it's a good representation of the sort of injury that can be produced by surgery."
###
Neuroscience postdoctoral fellow E.D. Crown also co-authored the paper. The research was supported by grants from the John S. Dunn Research Foundation and the West Endowment, as well as the Frank A. Liddell, Jr. Fund of the Greater Houston Community Foundation, TIRR Foundation's Mission Connect program and the National Institutes of Health.
Contact: Jim Kelly
University of Texas Medical Branch at Galveston
FBSS occurs when surgery either fails to cure back pain or leads to additional chronic pain after a spinal operation.
In experiments using laboratory rats, neuroscientists at the University of Texas Medical Branch at Galveston (UTMB) applied the local anesthetic Lidocaine to the animals' exposed spinal cords before subjecting the rats to simulated spinal surgery. They found the procedure prevented both the release of chemicals associated with FBSS and behavior typical of animals experiencing FBSS-caused pain.
A paper describing their investigation is in press at the journal Experimental Neurology, and will be available January 26 at the journal's Web site in the "Articles in Press" section.
"Our hypothesis is that the unintentional stretching and compression that can occur in the spinal cord during surgery causes the release of large quantities of chemicals called excitatory amino acids, which produce a toxic environment in the spine and cause long-term hyperexcitability in spinal neurons, generating chronic neuropathic pain - pain produced in the nerves themselves," said UTMB neuroscience and cell biology professor Claire Hulsebosch, a senior author of the paper along with UTMB neuroscience and cell biology professor David J. McAdoo. "When we applied Lidocaine to the surface of the spinal cord before conducting our surgery," Hulsebosch continued, "we found that those releases were completely blocked."
In addition, Hulsebosch noted, rats whose spines had been pretreated with the local anesthetic showed less sensitivity and scored much lower than non-treated rats on a standard test for symptoms of neuropathic pain. In the test, steadily increasing pressure is applied to a rat's hind paws with fishing-line-like filaments. Rats experiencing the hypersensitivity associated with chronic pain tend to withdraw their paws at very low pressures, while those without chronic nerve pain react only to much higher pressures.
Researchers involved in the experiment cautioned that FBSS is a somewhat loose diagnosis, one with multiple causes that also may include pre-existing conditions that spinal surgery does not successfully address. "It also has to be said that the model we used, in which we cut the nerves in the dorsal root on the surface of the spinal cord, involved a severe injury," said UTMB neuroscience graduate student and first author Brian Rooney "But we think it's a good representation of the sort of injury that can be produced by surgery."
###
Neuroscience postdoctoral fellow E.D. Crown also co-authored the paper. The research was supported by grants from the John S. Dunn Research Foundation and the West Endowment, as well as the Frank A. Liddell, Jr. Fund of the Greater Houston Community Foundation, TIRR Foundation's Mission Connect program and the National Institutes of Health.
Contact: Jim Kelly
University of Texas Medical Branch at Galveston
Role Of Anesthetics In Alzheimer's Disease
Inhaled anesthetics commonly used in surgery are more likely to cause the aggregation of Alzheimer's disease-related plaques in the brain than intravenous anesthetics say University of Pittsburgh School of Medicine researchers in a journal article published in Biochemistry. This is the first report using state-of-the-art nuclear magnetic resonance (NMR) spectroscopic technique to explain the detailed molecular mechanism behind the aggregation of amyloid B (AB) peptide due to various anesthetics.
AB plaques are found in the brains of people with Alzheimer's disease. Many believe that the uncontrolled clumping of AB is the cause of Alzheimer's disease and that the similar aggregation of peptides and proteins play a role in the development of other neurodegenerative diseases such as Parkinson's disease.
"Many people know of or have heard of an elderly person who went into surgery where they received anesthesia and when they woke up they had noticeable memory loss or cognitive dysfunction," said Pravat K. Mandal, Ph.D., assistant professor of psychiatry, University of Pittsburgh School of Medicine and lead author of the study. Previous studies by the Pittsburgh researchers found that the inhaled anesthetics halothane and isoflurane and the intravenous anesthetic propofol encouraged the growth and clumping of AB in a test tube experiment.
"Our prior research had shown in molecular models that anesthetics may play a role by causing amyloid peptides to clump together - something that is thought to signal the advancement of Alzheimer's disease. In this study, we set out to see why this was happening and to determine if any one form of anesthesia might be a safer option than another," said Dr. Mandal.
In this study the researchers used NMR spectroscopy to determine how the inhaled anesthetics halothane and isoflurane and the intravenous anesthetics propofol and thiopental interact with AB influencing the aggregation of AB in forms commonly found in the brains of people with Alzheimer's disease. The results were strikingly different between the inhaled and injected anesthetics. The inhaled halothane and isoflurane had the most potent interaction with AB peptides causing the highest levels of AB aggregation. The injected anesthetic propofol only interacted and caused aggregation at high concentrations - interaction was not evident at lower concentrations. The intravenous thiopental did not cause the clustering of AB peptides even at high concentrations. Additionally, the molecular details for the interaction of these anesthetics with AB peptide were revealed.
Dr. Mandal noted that if the same thing occurs in humans, anesthetics could lead to more amyloid plaques which may lead to earlier memory problems, warranting further studies of anesthetics with AB both in laboratory and clinical settings.
###
The study was partly funded through grants from the American Parkinson Disease Association and American Health Assistance Foundation.
Contact: Jocelyn Uhl Duffy
University of Pittsburgh Medical Center
AB plaques are found in the brains of people with Alzheimer's disease. Many believe that the uncontrolled clumping of AB is the cause of Alzheimer's disease and that the similar aggregation of peptides and proteins play a role in the development of other neurodegenerative diseases such as Parkinson's disease.
"Many people know of or have heard of an elderly person who went into surgery where they received anesthesia and when they woke up they had noticeable memory loss or cognitive dysfunction," said Pravat K. Mandal, Ph.D., assistant professor of psychiatry, University of Pittsburgh School of Medicine and lead author of the study. Previous studies by the Pittsburgh researchers found that the inhaled anesthetics halothane and isoflurane and the intravenous anesthetic propofol encouraged the growth and clumping of AB in a test tube experiment.
"Our prior research had shown in molecular models that anesthetics may play a role by causing amyloid peptides to clump together - something that is thought to signal the advancement of Alzheimer's disease. In this study, we set out to see why this was happening and to determine if any one form of anesthesia might be a safer option than another," said Dr. Mandal.
In this study the researchers used NMR spectroscopy to determine how the inhaled anesthetics halothane and isoflurane and the intravenous anesthetics propofol and thiopental interact with AB influencing the aggregation of AB in forms commonly found in the brains of people with Alzheimer's disease. The results were strikingly different between the inhaled and injected anesthetics. The inhaled halothane and isoflurane had the most potent interaction with AB peptides causing the highest levels of AB aggregation. The injected anesthetic propofol only interacted and caused aggregation at high concentrations - interaction was not evident at lower concentrations. The intravenous thiopental did not cause the clustering of AB peptides even at high concentrations. Additionally, the molecular details for the interaction of these anesthetics with AB peptide were revealed.
Dr. Mandal noted that if the same thing occurs in humans, anesthetics could lead to more amyloid plaques which may lead to earlier memory problems, warranting further studies of anesthetics with AB both in laboratory and clinical settings.
###
The study was partly funded through grants from the American Parkinson Disease Association and American Health Assistance Foundation.
Contact: Jocelyn Uhl Duffy
University of Pittsburgh Medical Center
Empi Announces FDA Clearance Of Select(TM) TENS Device
Empi, a global market leader in non-invasive, non-systemic pain management and physical rehabilitation for more than 30 years, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance to market the Empi Select(TM) TENS (Transcutaneous Electrical Nerve Stimulation) device.
The Select(TM) device is designed specifically for the relief of chronic, arthritic, and post-surgical pain. The portable device can be used at home or on-the-go, and integrates site specific, preset treatment programs that make it convenient and easy-to-use. This feature ensures that the patient receives the appropriate electrotherapy treatment, specific to their condition and treatment site.
John Velure, Empi's Senior Director of Marketing, said, "The Select(TM) product is the first in a new generation of pain-management devices that are so easy to use that we believe patients will be more compliant and achieve more predictable pain relief than any of its predecessors. We believe that healthcare providers will take great comfort in knowing that their patients are getting the most appropriate treatment for their specific conditions."
The Select(TM) device also includes a patented SMP waveform that delivers maximum pain relief through the use of both endorphin release and gate control pathways. "Empi's primary focus is to offer healthcare providers non-invasive, non-systemic solutions for managing pain, usually as a complement to standard pharmacotherapies," said Peter Baird, Group President - Therapeutic Devices of Encore Medical Corporation, parent company of Empi.
The Select(TM) device represents the cornerstone of Empi's brand revitalization efforts and is the first new electrotherapy device to be developed by Empi following its 2006 merger with Compex Technologies, Inc., which operated under the name Rehabilicare. The jointly developed product draws on the best of the engineering and legacy devices of both predecessor companies.
The Select(TM) device will be available from Family Practice, Pain Management, Orthopedic and other physicians in mid-February, 2007.
About Empi
Empi is a global medical technology leader in designing and manufacturing transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) devices, iontophoretic drug delivery systems, and splinting products used for pain management, rehabilitation and edema reduction in clinic, home healthcare, sports and occupational medicine settings. Empi is the largest operating division of Encore Medical Corporation, which is wholly owned by the Blackstone Group.
Further information is available at http://www.empi.com.
About Encore Medical Corporation
Encore Medical Corporation is a diversified orthopedic device company with leading positions in many of the markets in which it competes. Encore develops, manufactures and distributes a comprehensive range of high-quality orthopedic devices used for rehabilitation, pain management and physical therapy. It also develops, manufactures and distributes a comprehensive suite of surgical reconstructive implant products. Encore believes that it is one of a few orthopedic device companies that offer healthcare professionals and patients a diverse range of orthopedic rehabilitation and surgical reconstructive implant products addressing the complete spectrum of pre- operative, post-operative, clinical and home rehabilitation care.
Further information is available at http://www.encoremed.com.
About The Blackstone Group
The Blackstone Group, a global private investment and advisory firm, was founded in 1985. The firm has raised a total of approximately $59 billion for alternative asset investing since its formation, of which roughly $27 billion has been for private equity investing. The healthcare sector is one of Blackstone's core areas of focus, with current investments in pharmaceuticals, hospitals, nursing homes, healthcare services and health insurance. Blackstone's other core businesses include Private Real Estate Investing, Corporate Debt Investing, Hedge Funds, Mutual Fund Management, Private Placement, Marketable Alternative Asset Management, and Investment Banking Advisory Services.
Further information is available at http://www.blackstone.com.
Encore Medical Corporation
http://www.encoremed.com
The Select(TM) device is designed specifically for the relief of chronic, arthritic, and post-surgical pain. The portable device can be used at home or on-the-go, and integrates site specific, preset treatment programs that make it convenient and easy-to-use. This feature ensures that the patient receives the appropriate electrotherapy treatment, specific to their condition and treatment site.
John Velure, Empi's Senior Director of Marketing, said, "The Select(TM) product is the first in a new generation of pain-management devices that are so easy to use that we believe patients will be more compliant and achieve more predictable pain relief than any of its predecessors. We believe that healthcare providers will take great comfort in knowing that their patients are getting the most appropriate treatment for their specific conditions."
The Select(TM) device also includes a patented SMP waveform that delivers maximum pain relief through the use of both endorphin release and gate control pathways. "Empi's primary focus is to offer healthcare providers non-invasive, non-systemic solutions for managing pain, usually as a complement to standard pharmacotherapies," said Peter Baird, Group President - Therapeutic Devices of Encore Medical Corporation, parent company of Empi.
The Select(TM) device represents the cornerstone of Empi's brand revitalization efforts and is the first new electrotherapy device to be developed by Empi following its 2006 merger with Compex Technologies, Inc., which operated under the name Rehabilicare. The jointly developed product draws on the best of the engineering and legacy devices of both predecessor companies.
The Select(TM) device will be available from Family Practice, Pain Management, Orthopedic and other physicians in mid-February, 2007.
About Empi
Empi is a global medical technology leader in designing and manufacturing transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) devices, iontophoretic drug delivery systems, and splinting products used for pain management, rehabilitation and edema reduction in clinic, home healthcare, sports and occupational medicine settings. Empi is the largest operating division of Encore Medical Corporation, which is wholly owned by the Blackstone Group.
Further information is available at http://www.empi.com.
About Encore Medical Corporation
Encore Medical Corporation is a diversified orthopedic device company with leading positions in many of the markets in which it competes. Encore develops, manufactures and distributes a comprehensive range of high-quality orthopedic devices used for rehabilitation, pain management and physical therapy. It also develops, manufactures and distributes a comprehensive suite of surgical reconstructive implant products. Encore believes that it is one of a few orthopedic device companies that offer healthcare professionals and patients a diverse range of orthopedic rehabilitation and surgical reconstructive implant products addressing the complete spectrum of pre- operative, post-operative, clinical and home rehabilitation care.
Further information is available at http://www.encoremed.com.
About The Blackstone Group
The Blackstone Group, a global private investment and advisory firm, was founded in 1985. The firm has raised a total of approximately $59 billion for alternative asset investing since its formation, of which roughly $27 billion has been for private equity investing. The healthcare sector is one of Blackstone's core areas of focus, with current investments in pharmaceuticals, hospitals, nursing homes, healthcare services and health insurance. Blackstone's other core businesses include Private Real Estate Investing, Corporate Debt Investing, Hedge Funds, Mutual Fund Management, Private Placement, Marketable Alternative Asset Management, and Investment Banking Advisory Services.
Further information is available at http://www.blackstone.com.
Encore Medical Corporation
http://www.encoremed.com
Physical Therapy Can Help Relieve Boomers' Back Pain
Because of increasingly demanding jobs, hectic daily schedules, participating in recreational activities, and caring for children, grandchildren, and elderly parents, back pain is becoming a common thread among baby boomers. However, this generation is less resigned to simply accept the changes brought about by aging, says the American Physical Therapy Association (APTA).
Baby boomers, those born between 1946 and 1964 and who now make up one fourth of the U.S. population, are leading more active lifestyles than previous generations. "Baby boomers are as active as they were when they were younger, but now they're living with chronic low back pain or osteoarthritis," says Jennifer Gamboa, PT, DPT, OCS, MTC, owner of Body Dynamics, a physical therapy private practice in Arlington, VA. "These conditions as well as others can benefit greatly from physical therapy intervention."
Back pain among baby boomers will be the subject of a toll-free national hotline on Thursday, February 15, from 9:00 am until 5:00 pm, Eastern Standard Time, sponsored by the American Physical Therapy Association's Orthopaedic and Sports Physical Therapy Sections. Physical therapists will be on hand to answer questions about injury prevention, exercise, and ways to prevent back pain. The hotline is offered as a public service to help people learn how to minimize back pain and is not a substitute for a visit to a physical therapist or other health care professional.
"Frequently, patients may unknowingly exacerbate their pain by exercising improperly or by having poor posture," Gamboa said. Physical therapists can help to identify and correct those behaviors. Physical therapists work on increasing muscle strength and cardiovascular endurance, restoring and improving range of motion in joints, and decreasing muscle and joint pain.
Physical therapy interventions may include therapeutic exercise, manual therapy, and functional training, as well as exercises for strength, flexibility, and range of motion, and devices designed to rest or support the joint, such as orthotics or splints. "The goal of a physical therapist is to get you back to doing what you enjoy on a daily basis with as little discomfort as possible."
For those patients who either are just starting an exercise regime, or for injured weekend warriors just getting back in the game, Gamboa recommends starting off slowly and not doing too much too fast. She notes that physical therapists devise step-wise plans in order for patients to gain strength and mobility.
Gamboa also suggests investing in an ergonomically correct chair for work, taking frequent breaks from computers, and participating in stress-relieving activities, such as yoga or meditation, to offset back pain.
Physical therapists (PTs) are health care professionals who diagnose and treat individuals of all ages, from newborns to the elderly, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. PTs examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability.
The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as physical therapy news and information at http://www.apta.org/consumer.
American Physical Therapy Association
http://www.apta.org/
Baby boomers, those born between 1946 and 1964 and who now make up one fourth of the U.S. population, are leading more active lifestyles than previous generations. "Baby boomers are as active as they were when they were younger, but now they're living with chronic low back pain or osteoarthritis," says Jennifer Gamboa, PT, DPT, OCS, MTC, owner of Body Dynamics, a physical therapy private practice in Arlington, VA. "These conditions as well as others can benefit greatly from physical therapy intervention."
Back pain among baby boomers will be the subject of a toll-free national hotline on Thursday, February 15, from 9:00 am until 5:00 pm, Eastern Standard Time, sponsored by the American Physical Therapy Association's Orthopaedic and Sports Physical Therapy Sections. Physical therapists will be on hand to answer questions about injury prevention, exercise, and ways to prevent back pain. The hotline is offered as a public service to help people learn how to minimize back pain and is not a substitute for a visit to a physical therapist or other health care professional.
"Frequently, patients may unknowingly exacerbate their pain by exercising improperly or by having poor posture," Gamboa said. Physical therapists can help to identify and correct those behaviors. Physical therapists work on increasing muscle strength and cardiovascular endurance, restoring and improving range of motion in joints, and decreasing muscle and joint pain.
Physical therapy interventions may include therapeutic exercise, manual therapy, and functional training, as well as exercises for strength, flexibility, and range of motion, and devices designed to rest or support the joint, such as orthotics or splints. "The goal of a physical therapist is to get you back to doing what you enjoy on a daily basis with as little discomfort as possible."
For those patients who either are just starting an exercise regime, or for injured weekend warriors just getting back in the game, Gamboa recommends starting off slowly and not doing too much too fast. She notes that physical therapists devise step-wise plans in order for patients to gain strength and mobility.
Gamboa also suggests investing in an ergonomically correct chair for work, taking frequent breaks from computers, and participating in stress-relieving activities, such as yoga or meditation, to offset back pain.
Physical therapists (PTs) are health care professionals who diagnose and treat individuals of all ages, from newborns to the elderly, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. PTs examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability.
The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as physical therapy news and information at http://www.apta.org/consumer.
American Physical Therapy Association
http://www.apta.org/
Texas Back Institute Explores Dynamic Stabilization Procedures As Alternative To Traditional Spine Therapy
The SpineMark Clinical Research Organization at Texas Back Institute in Plano, Texas, has taken the next step in offering patients multiple treatment options for spine care. Spinal fusions continue to be the standard of care for treating many disabling degenerative spinal conditions. But spinal fusions are not appropriate for everyone. In a move to provide patients with alternative therapies, SpineMark CRO at TBI is now enrolling patients in several clinical trials using motion preservation spinal devices aimed at maintaining natural movement.
Back pain has become a way of life for more than 50 million people in the United States. In 2005, an estimated 1 million surgeries were performed to correct spinal problems. That number exceeds the combined total of surgeries to replace hips or knees. The growing number of people with degenerative disc disease has created a major industry based on spinal fusion technology and products.
Today, the treatment of back pain and spinal problems is at a major crossroad. On one side is the public's desire to address chronic back pain through less invasive methods. The result has put a focus on new technologies that use smaller surgical incisions, or other methods aimed at preserving motion of the disc space, many without the need for fusion. On the other side, the FDA and spine surgeons in the U.S. are showing restraint in order to properly evaluate these new techniques before considering them a new standard of care.
The demand from patients and insurance companies for better treatment options has persuaded surgeons to look at the alternatives as well as the success rate for traditional fusion surgery. Data shows that the majority of lumbar fusion patients receive benefits from surgery. Extremely high success rates can now be attained from fusion procedures, but despite that, only about two-thirds of patients enjoy significant relief from back pain or regain desired function. Those published statistics are among the reasons why surgeons and their patients are looking to emerging technologies and new systems to deal with these spinal issues in a different way.
Public support for these new technologies can be seen in the dramatic growth of the industry. Sales of the emerging spinal motion preserving devices are increasing at an annual rate of 50 percent and should exceed $1.5 billion by 2009.
Patients with chronic back problems can access many of the leading traditional and motion preservation spinal devices being tested in the U.S. through SpineMark CRO at TBI in Plano, Texas. Patients are encouraged to speak with a spine care provider to discuss which option is best for their individual case.
Research studies for new spinal devices are directed at patients who are looking for the latest technology to bring their lives closer to normal. And with some of the best physicians and surgeons in the field of spinal care conducting these studies, participants will have that opportunity at the SpineMark CRO at TBI clinical research site.
"While fusions continue to be the gold standard, dynamic spine stabilization is at the forefront of advances in spine care," said Marcy Rogers, President and CEO of SpineMark Corporation. "We value the opportunity to participate in trials that could lead to additional treatment options for patients in search of a therapy that is right for them."
The implant market is the fastest growing market in healthcare. "Studies say that it will increase by 15-20 percent over the next 10 years," said Dr. Jack Zigler, president of SpineMark CRO at TBI. "In the interest of patients, it is important to get the new devices evaluated as efficiently as possible. The SpineMark CRO at TBI not only boasts an extraordinary physician and surgeon investigator group, but has married it to a clinical research organization infrastructure with solid and proven experience in regulatory compliance, stringent data collection, and patient safety monitoring. That combination is the ideal model for clinical research."
About SpineMark CRO at TBI
SpineMark CRO at TBI is the research arm for Texas Back Institute (TBI). TBI is one of the largest freestanding spine specialty clinics in the United States. The Institute, based in Plano, Texas, was established in 1978 and provides comprehensive medical care for individuals with back and neck pain. As an academic health care organization, TBI has trained hundreds of physicians, scientists and allied health professionals. SpineMark CRO at TBI employs state-of-the-art technology and research to treat patients and is involved in the most clinical trials of artificial discs. The professional staff there includes board-certified spine surgeons, general surgeons, internists, chiropractors, physiatrists, pain specialists, exercise physiologists and a team of physical and occupational therapists. SpineMark CRO at TBI's main office is located in Plano, Texas.
SpineMark Clinical Research Organization
SpineMark Clinical Research Organization
Back pain has become a way of life for more than 50 million people in the United States. In 2005, an estimated 1 million surgeries were performed to correct spinal problems. That number exceeds the combined total of surgeries to replace hips or knees. The growing number of people with degenerative disc disease has created a major industry based on spinal fusion technology and products.
Today, the treatment of back pain and spinal problems is at a major crossroad. On one side is the public's desire to address chronic back pain through less invasive methods. The result has put a focus on new technologies that use smaller surgical incisions, or other methods aimed at preserving motion of the disc space, many without the need for fusion. On the other side, the FDA and spine surgeons in the U.S. are showing restraint in order to properly evaluate these new techniques before considering them a new standard of care.
The demand from patients and insurance companies for better treatment options has persuaded surgeons to look at the alternatives as well as the success rate for traditional fusion surgery. Data shows that the majority of lumbar fusion patients receive benefits from surgery. Extremely high success rates can now be attained from fusion procedures, but despite that, only about two-thirds of patients enjoy significant relief from back pain or regain desired function. Those published statistics are among the reasons why surgeons and their patients are looking to emerging technologies and new systems to deal with these spinal issues in a different way.
Public support for these new technologies can be seen in the dramatic growth of the industry. Sales of the emerging spinal motion preserving devices are increasing at an annual rate of 50 percent and should exceed $1.5 billion by 2009.
Patients with chronic back problems can access many of the leading traditional and motion preservation spinal devices being tested in the U.S. through SpineMark CRO at TBI in Plano, Texas. Patients are encouraged to speak with a spine care provider to discuss which option is best for their individual case.
Research studies for new spinal devices are directed at patients who are looking for the latest technology to bring their lives closer to normal. And with some of the best physicians and surgeons in the field of spinal care conducting these studies, participants will have that opportunity at the SpineMark CRO at TBI clinical research site.
"While fusions continue to be the gold standard, dynamic spine stabilization is at the forefront of advances in spine care," said Marcy Rogers, President and CEO of SpineMark Corporation. "We value the opportunity to participate in trials that could lead to additional treatment options for patients in search of a therapy that is right for them."
The implant market is the fastest growing market in healthcare. "Studies say that it will increase by 15-20 percent over the next 10 years," said Dr. Jack Zigler, president of SpineMark CRO at TBI. "In the interest of patients, it is important to get the new devices evaluated as efficiently as possible. The SpineMark CRO at TBI not only boasts an extraordinary physician and surgeon investigator group, but has married it to a clinical research organization infrastructure with solid and proven experience in regulatory compliance, stringent data collection, and patient safety monitoring. That combination is the ideal model for clinical research."
About SpineMark CRO at TBI
SpineMark CRO at TBI is the research arm for Texas Back Institute (TBI). TBI is one of the largest freestanding spine specialty clinics in the United States. The Institute, based in Plano, Texas, was established in 1978 and provides comprehensive medical care for individuals with back and neck pain. As an academic health care organization, TBI has trained hundreds of physicians, scientists and allied health professionals. SpineMark CRO at TBI employs state-of-the-art technology and research to treat patients and is involved in the most clinical trials of artificial discs. The professional staff there includes board-certified spine surgeons, general surgeons, internists, chiropractors, physiatrists, pain specialists, exercise physiologists and a team of physical and occupational therapists. SpineMark CRO at TBI's main office is located in Plano, Texas.
SpineMark Clinical Research Organization
SpineMark Clinical Research Organization
March 5, 2007
Chronic Pain Up Almost 40 Percent Among U.S. Workers In Past Decade
Persistent, chronic pain has risen dramatically among full-time U.S. workers in the past 10 years, but workers today opt to go to their jobs rather than call in sick, leading to a growing trend of presenteeism -- a negative impact on work despite being physically present at the job.
These data, released today, are from a 2006 national survey conducted by Harris Interactive(R) on "Pain in the Workplace" (http://www.painandwork.com), sponsored by PriCara(TM), Unit of Ortho-McNeil, Inc., and conducted in partnership with the National Pain Foundation (NPF). The survey was an update to the 1996 Louis Harris & Associates poll on the subject, sponsored by Ortho-McNeil Pharmaceutical, Inc.
"Chronic pain appears to be increasing in prevalence among U.S. workers as Americans age and lead more sedentary lifestyles," said Rollin Gallagher, M.D., M.P.H., editor-in-chief of the NPF Web site (http://www.NationalPainFoundation.org), a founding and current member of the Board of the NPF and clinical professor and director, Center for Pain Medicine, Research and Policy of the University of Pennsylvania. "This survey indicates that employees with chronic pain must become their own advocates, understand the impact of their chronic pain and work with their healthcare provider to identify appropriate treatment options."
Chronic pain, defined in the survey as pain that lasts for at least six months, was more common in the workplace in 2006 than it was in 1996 (26 percent vs. 19 percent).
Today, almost nine in 10 employees with chronic pain (89 percent) typically go to work rather than stay home when experiencing chronic pain, the survey found. The same percentage of employees (89 percent) reported experiencing chronic pain at work "often" or "sometimes." Ninety-five percent of employees with persistent, chronic pain reported that their pain must be moderately severe or very severe to cause them to stay home from work.
"In my practice, I am seeing an increasing number of patients for chronic pain and hearing more patients talk about how their pain affects activities of daily living," said Charles Argoff, M.D., director and assistant professor of neurology, New York University School of Medicine, New York, New York. "They're looking for ways to manage their pain, and there are treatments that can help such as diet and exercise, physical therapy, acupuncture and a variety of over-the-counter and prescription medications. Extended-release chronic pain medications, such as prescription ULTRAM(R) ER (tramadol HCl) Extended-Release Tablets, taken once daily, have been shown to relieve moderate to moderately severe chronic pain in adults who need around-the-clock treatment for an extended period of time(1)."
Addressing Pain at Work
There have been positive changes in the workplace in the last decade. More than two-thirds, or 66 percent, of employers surveyed now offer worksite wellness programs to employees, compared to 40 percent in 1996. But while the number of wellness programs is relatively high, the number of programs addressing chronic pain is not. Only 22 percent of wellness programs include a component about preventing or living with chronic pain conditions.
"We have seen some improvement in the recognition of pain-related illness in the workplace, and that should be commended," said Dr. Gallagher. "But more U.S. businesses should invest in these wellness programs. Once employees are given the tools to better understand and manage their pain successfully, they can begin to improve many areas of their lives affected by their chronic pain."
About ULTRAM(R) ER
Important Safety Information
Tell your healthcare professional if you have had an allergic reaction to tramadol or other opioids in the past.
ULTRAM ER must be swallowed whole, and must not be chewed, crushed or split.
Seizures have been reported in people taking tramadol, the medicine in ULTRAM ER. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids or other drugs that can cause seizures. Risk of convulsions may also increase in people with epilepsy or a history of seizures.
Talk to your doctor if you are suicidal or have a history of drug addiction. Also talk to your doctor if you are pregnant.
ULTRAM ER should be used with caution in people taking medications such as tranquilizers, hypnotics or other opioids or alcohol. ULTRAM ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.
The most common side effects reported with ULTRAM ER were dizziness, nausea, constipation, sleepiness and feeling flushed.
For additional information and to see the full Prescribing Information, visit http://www.ULTRAM-ER.com.
About the Survey
The original "Pain in the Workplace 1996" survey was conducted by Louis Harris & Associates on behalf of Ortho-McNeil Pharmaceutical, Inc. The current "Pain in the Workplace 2006" survey was conducted by Harris Interactive(R) on behalf of PriCara(TM), Unit of Ortho-McNeil, Inc.
The 2006 survey was conducted via telephone within the United States by Harris Interactive between October 30 and December 3, 2006 among 1,103 employed U.S. adults age 18+ and 251 employment benefits managers at non-headquartered locations with 150 or more employees at the site. For the employees, figures for age, gender, race/ethnicity, education and region were weighted where necessary to bring them into line with their actual proportions in the population. The data for employment benefits managers were not weighted and represent only the opinions of those surveyed. With a pure probability sample of 1,103 and 251, one could say with a ninety-five percent probability that the overall results have a sampling error of +/-3 percentage points and +/-6 percentage points, respectfully. Sampling error for sub-samples would be higher and would vary. However, that does not take other sources of error into account.
The methodologies for the 1996 and 2006 surveys were identical and allow for accurate comparisons to be made between the data sets.
For more information on the survey, visit http://www.painandwork.com.
About the National Pain Foundation
The National Pain Foundation, a non-profit 501(c)(3) organization, was established in 1998 to advance functional recovery of persons in pain through information, education, awareness and support. The organization was created to serve the 75 million Americans living with chronic pain. Its goal is to empower patients by helping people in pain become actively involved in the design of their treatment plan, exploring both traditional and complementary approaches to pain management. For more information on the NPF, visit http://www.nationalpainfoundation.org.
The National Pain Foundation does not endorse or recommend any specific treatment, procedure, or product.
About PriCara(TM), Unit of Ortho-McNeil, Inc.
Ortho-McNeil, Inc., a Johnson & Johnson company, is headquartered in Raritan, NJ, and provides innovative, high quality prescription treatments for healthcare providers and their patients in primary care, hospitals and other care facilities. PriCara(TM), Unit of Ortho-McNeil, Inc., is the only major healthcare organization in the United States solely dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. Ortho-McNeil, Inc., and PriCara provide medicines, education and resources in the areas of pain, gastrointestinal and infectious diseases. For more information about the company, please visit http://www.PriCara.com.
References
(1) The National Pain Foundation does not endorse or recommend any specific treatment, procedure, or product.
PriCara (TM), Unit of Ortho-McNeil, Inc.
http://www.PriCara.com
These data, released today, are from a 2006 national survey conducted by Harris Interactive(R) on "Pain in the Workplace" (http://www.painandwork.com), sponsored by PriCara(TM), Unit of Ortho-McNeil, Inc., and conducted in partnership with the National Pain Foundation (NPF). The survey was an update to the 1996 Louis Harris & Associates poll on the subject, sponsored by Ortho-McNeil Pharmaceutical, Inc.
"Chronic pain appears to be increasing in prevalence among U.S. workers as Americans age and lead more sedentary lifestyles," said Rollin Gallagher, M.D., M.P.H., editor-in-chief of the NPF Web site (http://www.NationalPainFoundation.org), a founding and current member of the Board of the NPF and clinical professor and director, Center for Pain Medicine, Research and Policy of the University of Pennsylvania. "This survey indicates that employees with chronic pain must become their own advocates, understand the impact of their chronic pain and work with their healthcare provider to identify appropriate treatment options."
Chronic pain, defined in the survey as pain that lasts for at least six months, was more common in the workplace in 2006 than it was in 1996 (26 percent vs. 19 percent).
Today, almost nine in 10 employees with chronic pain (89 percent) typically go to work rather than stay home when experiencing chronic pain, the survey found. The same percentage of employees (89 percent) reported experiencing chronic pain at work "often" or "sometimes." Ninety-five percent of employees with persistent, chronic pain reported that their pain must be moderately severe or very severe to cause them to stay home from work.
"In my practice, I am seeing an increasing number of patients for chronic pain and hearing more patients talk about how their pain affects activities of daily living," said Charles Argoff, M.D., director and assistant professor of neurology, New York University School of Medicine, New York, New York. "They're looking for ways to manage their pain, and there are treatments that can help such as diet and exercise, physical therapy, acupuncture and a variety of over-the-counter and prescription medications. Extended-release chronic pain medications, such as prescription ULTRAM(R) ER (tramadol HCl) Extended-Release Tablets, taken once daily, have been shown to relieve moderate to moderately severe chronic pain in adults who need around-the-clock treatment for an extended period of time(1)."
Addressing Pain at Work
There have been positive changes in the workplace in the last decade. More than two-thirds, or 66 percent, of employers surveyed now offer worksite wellness programs to employees, compared to 40 percent in 1996. But while the number of wellness programs is relatively high, the number of programs addressing chronic pain is not. Only 22 percent of wellness programs include a component about preventing or living with chronic pain conditions.
"We have seen some improvement in the recognition of pain-related illness in the workplace, and that should be commended," said Dr. Gallagher. "But more U.S. businesses should invest in these wellness programs. Once employees are given the tools to better understand and manage their pain successfully, they can begin to improve many areas of their lives affected by their chronic pain."
About ULTRAM(R) ER
Important Safety Information
Tell your healthcare professional if you have had an allergic reaction to tramadol or other opioids in the past.
ULTRAM ER must be swallowed whole, and must not be chewed, crushed or split.
Seizures have been reported in people taking tramadol, the medicine in ULTRAM ER. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids or other drugs that can cause seizures. Risk of convulsions may also increase in people with epilepsy or a history of seizures.
Talk to your doctor if you are suicidal or have a history of drug addiction. Also talk to your doctor if you are pregnant.
ULTRAM ER should be used with caution in people taking medications such as tranquilizers, hypnotics or other opioids or alcohol. ULTRAM ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.
The most common side effects reported with ULTRAM ER were dizziness, nausea, constipation, sleepiness and feeling flushed.
For additional information and to see the full Prescribing Information, visit http://www.ULTRAM-ER.com.
About the Survey
The original "Pain in the Workplace 1996" survey was conducted by Louis Harris & Associates on behalf of Ortho-McNeil Pharmaceutical, Inc. The current "Pain in the Workplace 2006" survey was conducted by Harris Interactive(R) on behalf of PriCara(TM), Unit of Ortho-McNeil, Inc.
The 2006 survey was conducted via telephone within the United States by Harris Interactive between October 30 and December 3, 2006 among 1,103 employed U.S. adults age 18+ and 251 employment benefits managers at non-headquartered locations with 150 or more employees at the site. For the employees, figures for age, gender, race/ethnicity, education and region were weighted where necessary to bring them into line with their actual proportions in the population. The data for employment benefits managers were not weighted and represent only the opinions of those surveyed. With a pure probability sample of 1,103 and 251, one could say with a ninety-five percent probability that the overall results have a sampling error of +/-3 percentage points and +/-6 percentage points, respectfully. Sampling error for sub-samples would be higher and would vary. However, that does not take other sources of error into account.
The methodologies for the 1996 and 2006 surveys were identical and allow for accurate comparisons to be made between the data sets.
For more information on the survey, visit http://www.painandwork.com.
About the National Pain Foundation
The National Pain Foundation, a non-profit 501(c)(3) organization, was established in 1998 to advance functional recovery of persons in pain through information, education, awareness and support. The organization was created to serve the 75 million Americans living with chronic pain. Its goal is to empower patients by helping people in pain become actively involved in the design of their treatment plan, exploring both traditional and complementary approaches to pain management. For more information on the NPF, visit http://www.nationalpainfoundation.org.
The National Pain Foundation does not endorse or recommend any specific treatment, procedure, or product.
About PriCara(TM), Unit of Ortho-McNeil, Inc.
Ortho-McNeil, Inc., a Johnson & Johnson company, is headquartered in Raritan, NJ, and provides innovative, high quality prescription treatments for healthcare providers and their patients in primary care, hospitals and other care facilities. PriCara(TM), Unit of Ortho-McNeil, Inc., is the only major healthcare organization in the United States solely dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. Ortho-McNeil, Inc., and PriCara provide medicines, education and resources in the areas of pain, gastrointestinal and infectious diseases. For more information about the company, please visit http://www.PriCara.com.
References
(1) The National Pain Foundation does not endorse or recommend any specific treatment, procedure, or product.
PriCara (TM), Unit of Ortho-McNeil, Inc.
http://www.PriCara.com
Risk For Stroke, Death Not Higher For Sickle Cell Children With Early Complications
Children with sickle cell disease who experienced major complications such as pain and lung disease early in life are at no greater risk for stroke or death during later childhood, new research from UT Southwestern Medical Center shows.
In addition, sickle cell children who have pain episodes ("crises") or dactylitis, a type of painful swelling of the hands and feet, as infants or toddlers are at no greater risk of having those symptoms recur in later childhood. The study's results, however, showed that children hospitalized for chest problems early on are more likely to see those problems recur up to adulthood.
The study following more than 200 children with sickle cell disease from birth through teenage years appears in the January issue of Blood, the scientific journal of the American Society of Hematology.
The findings are an important step in trying to identify predictors that reveal how the mysterious disease will progress as children age, said Dr. Charles Quinn, assistant professor of pediatrics at UT Southwestern and the study's lead author.
"Everybody who has sickle cell disease is affected differently by the disease. Some seem to have a lot of problems with pain and lung disease and some have very few problems and may have a normal life span," said Dr. Quinn. "We don't really understand why everyone with the same disease can be so different."
The myriad medical issues make it difficult when counseling parents of babies with sickle cell disease about what they can expect, he said. "We can't give them very much in the way of specifics, exactly what this child will likely go through or what to expect from the disease in the future," said Dr. Quinn, a pediatric hematology specialist at Children's Medical Center Dallas.
People with sickle cell disease have a genetic error in their hemoglobin. The disease turns the usually soft, round red blood cell that carries oxygen through the body into an inflexible, sickle-shaped cell that causes blockages in blood vessels and prevents body tissues from receiving oxygen. It is estimated that at least 70,000 Americans have the disease.
UT Southwestern researchers at Children's and at the National Institutes of Health-funded Southwestern Comprehensive Sickle Cell Center launched the study to try to determine whether problems from the disease in the first three years of life offered any indication of later problems.
They initially looked at whether some of the more common problems associated with sickle cell disease pain events, dactylitis and acute chest syndrome predicted early death or stroke. Researchers found that none of those factors result in higher risk.
But they did find that acute chest syndrome damaged lung tissue marked by fever, chest pain and difficulty breathing did correlate with recurrent episodes throughout the remainder of their childhood.
That may indicate a need for closer follow-up for those children and perhaps justify more aggressive treatment strategies.
Children hospitalized for acute chest syndrome and early painful events in the first three years also were at slightly higher risk for later painful episodes.
"Some doctors would think that if they have early pain, they are destined to have frequent pain later in life, but that's not necessarily the case," Dr. Quinn said.
The swelling condition dactylitis did not indicate any greater likelihood of pain episodes or lung disease up to adulthood, the UT Southwestern researchers found. "That finding in particular is at odds with other studies that showed that early dactylitis does predict later adverse outcomes," Dr. Quinn said.
Researchers reviewed cases of 264 children who are part of the Dallas Newborn Cohort, a unique patient pool started in 1983 when newborn screening for sickle cell disease was launched by the state. Researchers have been able to follow children with the disease to track how sickle cell patients fare. Earlier findings showed that children with sickle cell disease are living longer, dying less often from their disease and contracting fewer fatal infections than ever before.
Dr. Quinn said this latest step of identifying potential clinical signs is an important one for predicting the future for sickle-cell patients.
"This finding is something that could potentially be applied anywhere, whether you have a high-tech lab or you practice in a small clinic in a rural community," Dr. Quinn said. "We're always looking for something to help predict the future. Lots of investigators have looked at many laboratory markers with mixed results. What we did was to look at very simple, clinical manifestations of the disease that are easily seen by parents and by doctors and that didn't require any special laboratory or equipment to make this sort of prediction."
Also involved in the study were Dr. Zora Rogers, associate professor of pediatrics; Dr. George Buchanan, professor of pediatrics and director of the Southwestern Comprehensive Sickle Cell Center and the Barrett Family Center for Pediatric Oncology; and Elizabeth Shull, a registered nurse who collected the data.
About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members including four active Nobel Prize winners, more than any other medical school in the world are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
http://www.utsouthwestern.edu/
In addition, sickle cell children who have pain episodes ("crises") or dactylitis, a type of painful swelling of the hands and feet, as infants or toddlers are at no greater risk of having those symptoms recur in later childhood. The study's results, however, showed that children hospitalized for chest problems early on are more likely to see those problems recur up to adulthood.
The study following more than 200 children with sickle cell disease from birth through teenage years appears in the January issue of Blood, the scientific journal of the American Society of Hematology.
The findings are an important step in trying to identify predictors that reveal how the mysterious disease will progress as children age, said Dr. Charles Quinn, assistant professor of pediatrics at UT Southwestern and the study's lead author.
"Everybody who has sickle cell disease is affected differently by the disease. Some seem to have a lot of problems with pain and lung disease and some have very few problems and may have a normal life span," said Dr. Quinn. "We don't really understand why everyone with the same disease can be so different."
The myriad medical issues make it difficult when counseling parents of babies with sickle cell disease about what they can expect, he said. "We can't give them very much in the way of specifics, exactly what this child will likely go through or what to expect from the disease in the future," said Dr. Quinn, a pediatric hematology specialist at Children's Medical Center Dallas.
People with sickle cell disease have a genetic error in their hemoglobin. The disease turns the usually soft, round red blood cell that carries oxygen through the body into an inflexible, sickle-shaped cell that causes blockages in blood vessels and prevents body tissues from receiving oxygen. It is estimated that at least 70,000 Americans have the disease.
UT Southwestern researchers at Children's and at the National Institutes of Health-funded Southwestern Comprehensive Sickle Cell Center launched the study to try to determine whether problems from the disease in the first three years of life offered any indication of later problems.
They initially looked at whether some of the more common problems associated with sickle cell disease pain events, dactylitis and acute chest syndrome predicted early death or stroke. Researchers found that none of those factors result in higher risk.
But they did find that acute chest syndrome damaged lung tissue marked by fever, chest pain and difficulty breathing did correlate with recurrent episodes throughout the remainder of their childhood.
That may indicate a need for closer follow-up for those children and perhaps justify more aggressive treatment strategies.
Children hospitalized for acute chest syndrome and early painful events in the first three years also were at slightly higher risk for later painful episodes.
"Some doctors would think that if they have early pain, they are destined to have frequent pain later in life, but that's not necessarily the case," Dr. Quinn said.
The swelling condition dactylitis did not indicate any greater likelihood of pain episodes or lung disease up to adulthood, the UT Southwestern researchers found. "That finding in particular is at odds with other studies that showed that early dactylitis does predict later adverse outcomes," Dr. Quinn said.
Researchers reviewed cases of 264 children who are part of the Dallas Newborn Cohort, a unique patient pool started in 1983 when newborn screening for sickle cell disease was launched by the state. Researchers have been able to follow children with the disease to track how sickle cell patients fare. Earlier findings showed that children with sickle cell disease are living longer, dying less often from their disease and contracting fewer fatal infections than ever before.
Dr. Quinn said this latest step of identifying potential clinical signs is an important one for predicting the future for sickle-cell patients.
"This finding is something that could potentially be applied anywhere, whether you have a high-tech lab or you practice in a small clinic in a rural community," Dr. Quinn said. "We're always looking for something to help predict the future. Lots of investigators have looked at many laboratory markers with mixed results. What we did was to look at very simple, clinical manifestations of the disease that are easily seen by parents and by doctors and that didn't require any special laboratory or equipment to make this sort of prediction."
Also involved in the study were Dr. Zora Rogers, associate professor of pediatrics; Dr. George Buchanan, professor of pediatrics and director of the Southwestern Comprehensive Sickle Cell Center and the Barrett Family Center for Pediatric Oncology; and Elizabeth Shull, a registered nurse who collected the data.
About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members including four active Nobel Prize winners, more than any other medical school in the world are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
http://www.utsouthwestern.edu/
Emergency Departments Test Chest Pain Patients Differently, Based On Race, Gender And Insurance
The study, conducted by Liliana E. Pezzin, Ph.D., associate professor of medicine at the Medical College, along with co-investigators Gary B. Green, M.D., MPH, and Penelope Keyl, Ph.D., at Johns Hopkins, appears in the February 2007 issue of Academic Emergency Medicine.
Chest pain is the most common initial symptom in patients diagnosed with coronary artery disease. Tests such as electrocardiography, chest radiography as well as oxygen saturation monitoring and cardiac monitoring are non-invasive and useful in diagnosing the disease. The study found that these tests are applied differently based on patients' race, gender and insurance.
Researchers drew on data compiled by the National Hospital Ambulatory Health Care Survey of Emergency Departments (NHAMCS-ED), from 1995 to 2000, for patients 30 years old or older presenting with chest pain. The retrospective study used a sample of 7,068 patients which corresponded to 32 million visits nationally throughout the six-year period.
They found that the rate of visits to emergency departments by patients presenting with chest pain increased in the six-year period, and that race, gender and insurance differences were factors in the type of care patients received at emergency departments.
Overall, African American males were 25 to 30 percent less likely to receive any of the tests than non-African American males.
Use of all forms of diagnostic testing and monitoring, with the exception of oxygen saturation monitoring, decreased among male African American patients over the six-year period. Electrocardiography decreased more than 16 percent among male African American patients, and they were 26 percent less likely to be placed on cardiac monitoring in 2000 than they were in 1995.
Gender was also an issue in determining what tests are administered for patients presenting with chest pain. African American women were approximately five percent less likely to have electrocardiography tests than non-African American men.
African American women were also 17 percent less likely to undergo cardiac monitoring, 14 percent less likely to have oxygen saturation monitoring, and six percent less likely to have chest radiography tests than non-African American men. Similarly, the rate of testing was lower for non-African American women than it was for non-African American men.
Insurance type was also proven to have a significant role in the administration of tests. Patients covered by forms of insurance other than commercial insurance were approximately 13 percent less likely to undergo electrocardiography. Additionally, patients covered by these forms of insurance were almost 21 percent less likely to be placed on cardiac monitoring, 23 percent less likely to have oxygen saturation measured, and more than 13 percent less likely to receive chest radiography than patients covered by commercial insurance.
The study also found that approximately 82 percent of commercially insured non-African American men received electrocardiography testing when presenting with chest pain in 2000. This is nearly a 27 percent higher proportion than uninsured African American men, and a 31 percent higher proportion than African American men covered by non-commercial forms of insurance.
###
The study was funded, in part, by a grant from the Agency for Healthcare Research and Quality.
Contact: Toranj Marphetia
Medical College of Wisconsin
Chest pain is the most common initial symptom in patients diagnosed with coronary artery disease. Tests such as electrocardiography, chest radiography as well as oxygen saturation monitoring and cardiac monitoring are non-invasive and useful in diagnosing the disease. The study found that these tests are applied differently based on patients' race, gender and insurance.
Researchers drew on data compiled by the National Hospital Ambulatory Health Care Survey of Emergency Departments (NHAMCS-ED), from 1995 to 2000, for patients 30 years old or older presenting with chest pain. The retrospective study used a sample of 7,068 patients which corresponded to 32 million visits nationally throughout the six-year period.
They found that the rate of visits to emergency departments by patients presenting with chest pain increased in the six-year period, and that race, gender and insurance differences were factors in the type of care patients received at emergency departments.
Overall, African American males were 25 to 30 percent less likely to receive any of the tests than non-African American males.
Use of all forms of diagnostic testing and monitoring, with the exception of oxygen saturation monitoring, decreased among male African American patients over the six-year period. Electrocardiography decreased more than 16 percent among male African American patients, and they were 26 percent less likely to be placed on cardiac monitoring in 2000 than they were in 1995.
Gender was also an issue in determining what tests are administered for patients presenting with chest pain. African American women were approximately five percent less likely to have electrocardiography tests than non-African American men.
African American women were also 17 percent less likely to undergo cardiac monitoring, 14 percent less likely to have oxygen saturation monitoring, and six percent less likely to have chest radiography tests than non-African American men. Similarly, the rate of testing was lower for non-African American women than it was for non-African American men.
Insurance type was also proven to have a significant role in the administration of tests. Patients covered by forms of insurance other than commercial insurance were approximately 13 percent less likely to undergo electrocardiography. Additionally, patients covered by these forms of insurance were almost 21 percent less likely to be placed on cardiac monitoring, 23 percent less likely to have oxygen saturation measured, and more than 13 percent less likely to receive chest radiography than patients covered by commercial insurance.
The study also found that approximately 82 percent of commercially insured non-African American men received electrocardiography testing when presenting with chest pain in 2000. This is nearly a 27 percent higher proportion than uninsured African American men, and a 31 percent higher proportion than African American men covered by non-commercial forms of insurance.
###
The study was funded, in part, by a grant from the Agency for Healthcare Research and Quality.
Contact: Toranj Marphetia
Medical College of Wisconsin
Stem Cell Trial With Potential To Repair Hearts Damaged By Severe Coronary Artery Disease
Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject's own stem cells can treat a form of severe coronary artery disease.
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.
Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.
Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.
Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,
Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.
####
Coronary Artery Disease and Chronic Myocardial Ischemia
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
What are stem cells?
Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Source: National Institutes of Health
To participate in the study
The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..
About the NOGA Navigation System
The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.
The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.
The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Rush
Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Contact: Mary Ann Schultz
Rush University Medical Center
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.
Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.
Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.
Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,
Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.
####
Coronary Artery Disease and Chronic Myocardial Ischemia
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
What are stem cells?
Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Source: National Institutes of Health
To participate in the study
The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..
About the NOGA Navigation System
The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.
The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.
The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Rush
Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Contact: Mary Ann Schultz
Rush University Medical Center
Percutaneous Computerized Tomography Guided Renal Cryoablation Using Local Anesthesia: Pain Assessment
UroToday.com- As the technique of laparoscopic and open cryoablation of renal tumors has been popularized, an increasing number of investigators have continued to raise the bar attempting similar ablations using a percutaneous technique.
In the September issue of the Journal of Urology, Permpongkosol, Kavoussi and colleagues from Johns Hopkins and North Shore-Long Island Jewish Health System report their experience with 25 patients with 30 renal tumors treated with cryoablation using only local anesthesia.
The mean patient age was 67 years (range 33 to 80) with a mean tumor size of 2.1 cm. Mean ice ball size was 4.1 cm. A mean of 44 cc of 1% lidocaine was injected in the skin, subcutaneous tissue, muscle and renal capsule along the tracts where the cryotherapy probes would be placed. Ablations were performed in the prone position using CT guidance with an average treatment time of 68 minutes. Pain scores were assessed during and after the procedure (scale 0 to 1).
Pain scores were zero before and after the procedure in all patients. Mean pain score after the first freeze was 1.8. Successful completion of ablation with local anesthesia only was completed in 85% of patients. Mean time to recovery was 112 minutes. Five complications occurred, including contrast allergy, transhepatic probe insertion with hematoma, perinephric hematoma with pleural effusion (2 units transfused), and 2 patients with transient nausea.
While these data suggest that percutaneous renal cryoablation using only local anesthesia is feasible, the question remains, what is the down-side of administering intravenous sedation in this setting, since it may be given with minimal morbidity with the added amnestic effects. Perhaps if a patient with a 2.1 cm mass has too many co morbidities to undergo conscious sedation, his renal mass should undergo active surveillance.
PermpongkosolВ S, SulmanВ A, SolomonВ SB, GongВ GX, KavoussiВ LR
J Urol 176(3): 915-918, 2006.
Reviewed by UroToday.com Contributing Editor Ricardo SГЎnchez-Ortiz, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:
www.urotoday.com
Copyright © 2006 - UroToday
In the September issue of the Journal of Urology, Permpongkosol, Kavoussi and colleagues from Johns Hopkins and North Shore-Long Island Jewish Health System report their experience with 25 patients with 30 renal tumors treated with cryoablation using only local anesthesia.
The mean patient age was 67 years (range 33 to 80) with a mean tumor size of 2.1 cm. Mean ice ball size was 4.1 cm. A mean of 44 cc of 1% lidocaine was injected in the skin, subcutaneous tissue, muscle and renal capsule along the tracts where the cryotherapy probes would be placed. Ablations were performed in the prone position using CT guidance with an average treatment time of 68 minutes. Pain scores were assessed during and after the procedure (scale 0 to 1).
Pain scores were zero before and after the procedure in all patients. Mean pain score after the first freeze was 1.8. Successful completion of ablation with local anesthesia only was completed in 85% of patients. Mean time to recovery was 112 minutes. Five complications occurred, including contrast allergy, transhepatic probe insertion with hematoma, perinephric hematoma with pleural effusion (2 units transfused), and 2 patients with transient nausea.
While these data suggest that percutaneous renal cryoablation using only local anesthesia is feasible, the question remains, what is the down-side of administering intravenous sedation in this setting, since it may be given with minimal morbidity with the added amnestic effects. Perhaps if a patient with a 2.1 cm mass has too many co morbidities to undergo conscious sedation, his renal mass should undergo active surveillance.
PermpongkosolВ S, SulmanВ A, SolomonВ SB, GongВ GX, KavoussiВ LR
J Urol 176(3): 915-918, 2006.
Reviewed by UroToday.com Contributing Editor Ricardo SГЎnchez-Ortiz, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:
www.urotoday.com
Copyright © 2006 - UroToday
Supplemental Therapy Can Ease Pain For People Suffering From Common Jaw Disorder
A new supplemental therapy that teaches pain coping and biofeedback skills can reduce pain, the potential for chronic pain and health-care costs for millions of Americans suffering from a common jaw disorder, UT Southwestern Medical Center researchers have found.
The therapy certainly did the trick for Harriet Velevis, a Dallas pre-kindergarten teacher.
Her jaw used to throb with intense pain that made it hard to eat or do her job, and dental care provided little relief. But after participating in a UT Southwestern trial of the supplemental therapy, called early biopsychosocial intervention, she learned to self manage the pain. The intervention teaches a combination of coping techniques and tips on controlling stress-related bodily functions.
"Eventually I had no pain symptoms thanks to these techniques. I still use them today," Mrs. Velevis said. "For instance, I have a picture of a countryside scene in my classroom and I focus on it if I begin to grit my teeth or clench my jaw. Focusing on something that makes you happy helps your body relax."
UT Southwestern's trial evaluated early biopsychosocial intervention, which aims to help people at risk of developing chronic pain due to temporomandibular disorder, or TMD. The condition, which is associated with jaw or facial pain, affects more than 10 percent of Americans, making it the second-most common pain-causing muscular and skeletal condition, behind low-back pain.
Trial participants 20 men and 81 women who ranged in age from 18 to 70 were divided into two groups. One group got an intervention and standard dental care and the other received standard care alone.
The results, described in a study appearing online today in the Journal of the American Dental Association and in another study published in the journal's March 2006 issue, show that those who received the intervention had significantly lower levels of pain and fewer doctor visits.
Study participants in the intervention group also spent less money on treatment than those with no intervention, said Dr. Anna Stowell, assistant professor of psychiatry and anesthesiology and pain management at UT Southwestern and co-author of the studies. Standard care for TMD, such as medication, physical therapy and surgery, can be expensive.
"The early intervention can reduce TMD-related pain levels, stave off chronic pain and save people money on costly treatments," Dr. Stowell said.
In search of a low-cost supplement, researchers in this study combined two separately effective teaching techniques pain-coping and biofeedback skills into early biopsychosocial intervention.
The six-week intervention teaches patients about the mind-body relationship, the body's reaction to stress and relaxation training in everyday settings. Instruction also is given on biofeedback (the use of monitoring equipment attached to the body to record changes in muscle tension, respiration and temperature) to teach a person to control those functions generally considered involuntary.
About 50 of the study participants received the intervention and a year later reported reduced levels of pain. They also displayed improved coping abilities and better moods and emotions, Dr. Stowell said. The other half of the participants, who did not undergo intervention, made many more trips to a doctor to seek pain treatment. They also reported more general anxiety and other disorders.
"The intervention really helps people become more capable of managing pain," said Dr. Stowell, who works at the Eugene McDermott Center for Pain Management.
Other UT Southwestern researchers involved in the JADA study were Dr. Edward Ellis, professor of oral and maxillofacial surgery, and Dr. Robert Gatchel, clinical professor of anesthesiology and pain management and professor and chairman of psychology at UT Arlington. Another UT Arlington researcher and a Richardson dentist also were involved.
The National Institutes of Health-funded study has earned the Giddon Award for Distinguished Research in the Behavioral Sciences from the International Association of Dental Research.
About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members including four active Nobel Prize winners, more than any other medical school in the world are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
http://www.utsouthwestern.edu/
The therapy certainly did the trick for Harriet Velevis, a Dallas pre-kindergarten teacher.
Her jaw used to throb with intense pain that made it hard to eat or do her job, and dental care provided little relief. But after participating in a UT Southwestern trial of the supplemental therapy, called early biopsychosocial intervention, she learned to self manage the pain. The intervention teaches a combination of coping techniques and tips on controlling stress-related bodily functions.
"Eventually I had no pain symptoms thanks to these techniques. I still use them today," Mrs. Velevis said. "For instance, I have a picture of a countryside scene in my classroom and I focus on it if I begin to grit my teeth or clench my jaw. Focusing on something that makes you happy helps your body relax."
UT Southwestern's trial evaluated early biopsychosocial intervention, which aims to help people at risk of developing chronic pain due to temporomandibular disorder, or TMD. The condition, which is associated with jaw or facial pain, affects more than 10 percent of Americans, making it the second-most common pain-causing muscular and skeletal condition, behind low-back pain.
Trial participants 20 men and 81 women who ranged in age from 18 to 70 were divided into two groups. One group got an intervention and standard dental care and the other received standard care alone.
The results, described in a study appearing online today in the Journal of the American Dental Association and in another study published in the journal's March 2006 issue, show that those who received the intervention had significantly lower levels of pain and fewer doctor visits.
Study participants in the intervention group also spent less money on treatment than those with no intervention, said Dr. Anna Stowell, assistant professor of psychiatry and anesthesiology and pain management at UT Southwestern and co-author of the studies. Standard care for TMD, such as medication, physical therapy and surgery, can be expensive.
"The early intervention can reduce TMD-related pain levels, stave off chronic pain and save people money on costly treatments," Dr. Stowell said.
In search of a low-cost supplement, researchers in this study combined two separately effective teaching techniques pain-coping and biofeedback skills into early biopsychosocial intervention.
The six-week intervention teaches patients about the mind-body relationship, the body's reaction to stress and relaxation training in everyday settings. Instruction also is given on biofeedback (the use of monitoring equipment attached to the body to record changes in muscle tension, respiration and temperature) to teach a person to control those functions generally considered involuntary.
About 50 of the study participants received the intervention and a year later reported reduced levels of pain. They also displayed improved coping abilities and better moods and emotions, Dr. Stowell said. The other half of the participants, who did not undergo intervention, made many more trips to a doctor to seek pain treatment. They also reported more general anxiety and other disorders.
"The intervention really helps people become more capable of managing pain," said Dr. Stowell, who works at the Eugene McDermott Center for Pain Management.
Other UT Southwestern researchers involved in the JADA study were Dr. Edward Ellis, professor of oral and maxillofacial surgery, and Dr. Robert Gatchel, clinical professor of anesthesiology and pain management and professor and chairman of psychology at UT Arlington. Another UT Arlington researcher and a Richardson dentist also were involved.
The National Institutes of Health-funded study has earned the Giddon Award for Distinguished Research in the Behavioral Sciences from the International Association of Dental Research.
About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members including four active Nobel Prize winners, more than any other medical school in the world are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
5323 Harry Hines Blvd.
Dallas, TX 75390-9060
United States
http://www.utsouthwestern.edu/
Baxter Receives Clearance From U.S. FDA For Ipump Pain Management System 510(k)
Baxter Healthcare Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) on its upgraded Ipump Pain Management System 510(k) notification.
Baxter plans to resume selling the upgraded Ipump Pain Management System, which is used primarily in hospitals for controlled delivery of pain medicines, in the U.S. and international markets in second quarter 2007. Baxter also plans to launch the Ipump system in two new geographies.
"We are pleased to be able to meet the growing need for electronic infusion pumps for pain management with the reintroduction of the Ipump system," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The Ipump system allows patients to actively participate in managing their pain while in the hospital. After a clinician programs the pump, patients have the ability to control administration of their pain medicine at regulated intervals resulting in improved pain management."
Baxter placed Ipump Pain Management Systems on hold in July 2005 and subsequently developed upgraded hardware and software for the product. Existing and new Ipump systems will receive updated hardware and software that reduces the occurrence of certain error codes and improves the programming process to better match clinical application. In addition, the pumps will receive new Patient-Controlled Analgesia user controls designed to be more durable with a comfortable ergonomic shape. Upgrades to Ipump systems outside the U.S. have begun and customers in the U.S. will begin receiving upgrades in second quarter 2007.
About the Ipump System
The Ipump Pain Management System is indicated for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, and epidural, and for regional or local analgesia applications.
About Baxter
Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This release includes forward-looking statements concerning our plans to resume selling an upgraded Ipump Pain Management System in existing and new geographic markets and the deployment of modifications with respect to such devices currently in the market. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future actions by the FDA and other regulatory bodies and government authorities with respect to the upgraded Ipump Pain Management System; our ability to make the upgraded Ipump Pain Management System available for sale in accordance with our plans; our ability to deploy modifications on a timely basis with respect to Ipump Pain Management Systems currently in the market; and other risks identified in Baxter International Inc.'s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
Baxter Healthcare Corporation
http://www.baxter.com
Baxter plans to resume selling the upgraded Ipump Pain Management System, which is used primarily in hospitals for controlled delivery of pain medicines, in the U.S. and international markets in second quarter 2007. Baxter also plans to launch the Ipump system in two new geographies.
"We are pleased to be able to meet the growing need for electronic infusion pumps for pain management with the reintroduction of the Ipump system," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The Ipump system allows patients to actively participate in managing their pain while in the hospital. After a clinician programs the pump, patients have the ability to control administration of their pain medicine at regulated intervals resulting in improved pain management."
Baxter placed Ipump Pain Management Systems on hold in July 2005 and subsequently developed upgraded hardware and software for the product. Existing and new Ipump systems will receive updated hardware and software that reduces the occurrence of certain error codes and improves the programming process to better match clinical application. In addition, the pumps will receive new Patient-Controlled Analgesia user controls designed to be more durable with a comfortable ergonomic shape. Upgrades to Ipump systems outside the U.S. have begun and customers in the U.S. will begin receiving upgrades in second quarter 2007.
About the Ipump System
The Ipump Pain Management System is indicated for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, and epidural, and for regional or local analgesia applications.
About Baxter
Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This release includes forward-looking statements concerning our plans to resume selling an upgraded Ipump Pain Management System in existing and new geographic markets and the deployment of modifications with respect to such devices currently in the market. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future actions by the FDA and other regulatory bodies and government authorities with respect to the upgraded Ipump Pain Management System; our ability to make the upgraded Ipump Pain Management System available for sale in accordance with our plans; our ability to deploy modifications on a timely basis with respect to Ipump Pain Management Systems currently in the market; and other risks identified in Baxter International Inc.'s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
Baxter Healthcare Corporation
http://www.baxter.com
Painkiller Helps Against Child Cancer
Neuroblastoma is a form of cancer that develops in the nervous system and it affects small children more commonly than any other tumour type. Now, however, scientists at Karolinska Institutet in Sweden can show that a common painkiller can inhibit the development of neuroblastoma and help make treatment of the disease more effective.
The results apply to celecoxib, an analgesic, anti-inflammatory substance that works by inhibiting the effect of the inflammatory enzyme, Cox-2. In a study presented in Clinical Cancer Research, the research group has shown that celecoxib is also active against neuroblastoma, a type of tumour that depends on Cox-2 for its growth and proliferation.
The scientists have shown that celecoxib has an inhibitory and preventative effect on tumour development in rats. The substance also proved able to reinforce the effect of different cytostatics currently in use in the treatment of neuroblastoma.
"The painkiller can check the rapid division and growth of the cancer cells and block the blood vessels that supply the tumour with oxygen and nutrients," says John Inge Johnsen, researcher in child cancer at Karolinska Institutet.
The researchers conclude that celecoxib is a potential anti-neuroblastoma drug, possibly in combination with other drugs.
"But it's a matter of finding the right combination, as celecoxib can also counteract the tumouricidal effects of certain cytostatics," says Per Kogner, Professor at Karolinska Institutet and paediatrician at the Astrid Lindgren Children's Hospital in Stockholm.
The results from cell cultures and animals were obtained at concentrations that the scientists had previously measured in children receiving the medicine. They now plan to proceed to clinical trials, which will determine the way in which celecoxib can be used to treat neuroblastoma in children.
The research was conducted with the support of the Children's Cancer Foundation and the Swedish Cancer Society.
KAROLINSKA INSTITUTET
SE-171 77 Stockholm
http://info.ki.se/index_se.html
The results apply to celecoxib, an analgesic, anti-inflammatory substance that works by inhibiting the effect of the inflammatory enzyme, Cox-2. In a study presented in Clinical Cancer Research, the research group has shown that celecoxib is also active against neuroblastoma, a type of tumour that depends on Cox-2 for its growth and proliferation.
The scientists have shown that celecoxib has an inhibitory and preventative effect on tumour development in rats. The substance also proved able to reinforce the effect of different cytostatics currently in use in the treatment of neuroblastoma.
"The painkiller can check the rapid division and growth of the cancer cells and block the blood vessels that supply the tumour with oxygen and nutrients," says John Inge Johnsen, researcher in child cancer at Karolinska Institutet.
The researchers conclude that celecoxib is a potential anti-neuroblastoma drug, possibly in combination with other drugs.
"But it's a matter of finding the right combination, as celecoxib can also counteract the tumouricidal effects of certain cytostatics," says Per Kogner, Professor at Karolinska Institutet and paediatrician at the Astrid Lindgren Children's Hospital in Stockholm.
The results from cell cultures and animals were obtained at concentrations that the scientists had previously measured in children receiving the medicine. They now plan to proceed to clinical trials, which will determine the way in which celecoxib can be used to treat neuroblastoma in children.
The research was conducted with the support of the Children's Cancer Foundation and the Swedish Cancer Society.
KAROLINSKA INSTITUTET
SE-171 77 Stockholm
http://info.ki.se/index_se.html
Relationship Of Neonatologists' End Of Life Decisions To Their Personal Fear Of Death
Doctors who fear their own death say they are more prepared than other doctors to hasten death in sick newborns for whom further medical treatment is considered futile, reveals research published ahead of print in the Fetal & Neonatal Edition of Archives of Disease in Childhood.
The findings are based on an anonymous survey of 138 doctors specialising in the care of sick newborns (neonatologists) across Australia and New Zealand.
The doctors were asked questions about their ethical practice and to complete the Multidimensional Fear of Death Scale (MFODS), which measures different facets of personal fear of death.
Of the 138 doctors contacted, 78 (56%) completed the questionnaire. Virtually all of them said they sometimes withheld or withdrew life-sustaining treatment in newborns with severe mental and/or physical disability and those for whom further medical treatment was considered to be "overly burdensome" or futile.
They said they used painkillers or sedatives in both situations to alleviate pain and suffering, but without intending to hasten death.
But one in three specialists was prepared to use painkillers or sedatives to relieve pain and suffering by intentionally hastening death in newborns with severe disability.
And more than three out of four were prepared to hasten death for this purpose in babies for whom further treatment was considered futile.
In this situation, they preferred to use painkillers or sedatives to hasten death rather than withhold minimal treatment, such as tube feeds or oxygen, in a bid to prevent unnecessary pain and suffering.
But one in five neonatologists said that hastening death in this context was unacceptable by either means.
There was a link between the neonatologists' personal fear of death and their ethical practice.
Doctors who said they were not prepared to hasten death had significantly less fear of the "dying process" and of "premature death" than those prepared to hasten death with painkillers or sedatives. But they had significantly more "fear of being destroyed."
The author suggests that doctors' fear of the dying process or of premature death may unconsciously motivate them to hasten a newborn's death in order to relieve their own death anxiety.
Similarly, those who fear being "destroyed" may not be prepared to hasten death, because of their own fears, even though this may be the most humane way to relieve a newborn's suffering.
In an accompanying editorial, Martin Ward Platt points out that the findings should not be interpreted as indicative of rampant euthanasia on neonatal units.
Rather, he says, the study shows that "In relation to neonatal death and dying, doctors' fear, or lack of it, matters. It matters because it can influence clinical judgements."
He adds: "Recognising this difference is an important aspect of self knowledge, and there is a case to be made for all of us to be more open about it."
###
Contact: Emma Dickinson
BMJ Specialty Journals
The findings are based on an anonymous survey of 138 doctors specialising in the care of sick newborns (neonatologists) across Australia and New Zealand.
The doctors were asked questions about their ethical practice and to complete the Multidimensional Fear of Death Scale (MFODS), which measures different facets of personal fear of death.
Of the 138 doctors contacted, 78 (56%) completed the questionnaire. Virtually all of them said they sometimes withheld or withdrew life-sustaining treatment in newborns with severe mental and/or physical disability and those for whom further medical treatment was considered to be "overly burdensome" or futile.
They said they used painkillers or sedatives in both situations to alleviate pain and suffering, but without intending to hasten death.
But one in three specialists was prepared to use painkillers or sedatives to relieve pain and suffering by intentionally hastening death in newborns with severe disability.
And more than three out of four were prepared to hasten death for this purpose in babies for whom further treatment was considered futile.
In this situation, they preferred to use painkillers or sedatives to hasten death rather than withhold minimal treatment, such as tube feeds or oxygen, in a bid to prevent unnecessary pain and suffering.
But one in five neonatologists said that hastening death in this context was unacceptable by either means.
There was a link between the neonatologists' personal fear of death and their ethical practice.
Doctors who said they were not prepared to hasten death had significantly less fear of the "dying process" and of "premature death" than those prepared to hasten death with painkillers or sedatives. But they had significantly more "fear of being destroyed."
The author suggests that doctors' fear of the dying process or of premature death may unconsciously motivate them to hasten a newborn's death in order to relieve their own death anxiety.
Similarly, those who fear being "destroyed" may not be prepared to hasten death, because of their own fears, even though this may be the most humane way to relieve a newborn's suffering.
In an accompanying editorial, Martin Ward Platt points out that the findings should not be interpreted as indicative of rampant euthanasia on neonatal units.
Rather, he says, the study shows that "In relation to neonatal death and dying, doctors' fear, or lack of it, matters. It matters because it can influence clinical judgements."
He adds: "Recognising this difference is an important aspect of self knowledge, and there is a case to be made for all of us to be more open about it."
###
Contact: Emma Dickinson
BMJ Specialty Journals
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