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
April 15, 2007
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
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
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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
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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/
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