Keeping you up to date on recent developments in orthopedics

Less painful, more effective joint injections using ultrasound . . . The use of ultrasound needle guidance improves the performance, outcomes and the cost-effectiveness of knee injections in people with osteoarthritis, according to research presented this week at the American College of Rheumatology (ACR; Atlanta) Annual Scientific Meeting in Atlanta. Osteoarthritis, or OA as it is commonly called, is the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage the cushioning material at the end of long bones and causes changes in the structures around the joint. These changes can include fluid accumulation, bony overgrowth, and loosening and weakness of muscles and tendons, all of which may limit movement and cause pain and swelling. Researchers recently set out to determine if the use of ultrasound guidance would affect the outcomes of intraarticular injections injections of medicine into, or removal of fluid from, arthritic joints in people with knee OA. "Ultrasound, the use of sound waves to visualize the human body, is useful to physicians to guide the needle into the joint to inject medications to treat arthritis," said Wilmer Sibbitt, Jr., MD; professor of rheumatology and neurology, University of New Mexico Health Sciences Center (Albuquerque, New Mexico) and an investigator in the study. Sibbitt's research team studied 94 knees, which were randomly selected for injection administered either by the conventional palpation-guided method or by the newer ultrasound-guided method (which allowed researchers to watch, in real time, the needle entering and exiting the joint). Both the palpation and ultrasound-guided methods involved one needle, with a syringe attached, entering the joint to remove fluid from it. After that was accomplished, the first syringe was removed (with the needle remaining inserted) and a second syringe was used to inject 80 mg of a corticosteroid through the same needle. This technique ensured the medication was injected into the correct place. When using the ultrasound-guided method, researchers were able to perform the procedure while confirming needle placement as well as administration of the lidocaine and the corticosteroid by viewing the procedure as it occurred. Each participant's initial pain, pain during the procedure, and knee pain at the end of two weeks and six months were studied. When compared to the palpation-guided method, researchers found the use of the ultrasound-guided method to provide improved results including a 107% increase in the number of people who responded to the treatment and a 51.6% reduction in the number of people who did not.

Cedars-Sinai awarded $1.9 million Cirm grant to develop stem cell treatments . . . A team of physicians and scientists from the Cedars-Sinai Regenerative Medicine Institute (Los Angeles) and Department of Surgery, led by Dan Gazit, DMD, PhD has been awarded a three-year $1.9 million grant from the California stem cell agency to fund research leading to clinical trials for what could become the first biological treatment for the most common type of bone fracture in osteoporosis patients. The grant was announced Thursday by the California Institute of Regenerative Medicine as one of 19 Early Translation II Awards aimed at developing a new stem cell therapy for an unmet medical need or clearing up a bottleneck in the development of new therapies."Vertebral fractures are a common, painful problem for adults with osteoporosis and it can cause severe back pain and disabilities," said Gazit. "Currently, there are not many effective options for treatment so our goal is to develop a biological treatment that not only promotes healing but also stimulates normal bone production." Vertebral compression fractures account for approximately 700,000 injuries in the U.S. each year - twice as many as hip fractures. Medical therapy and research have focused mainly on prevention, but when compression fractures occur, the only medical interventions available involve injection of synthetic, non-biological material that does not absorb into tissues and remains a permanent foreign body fixture in the spine. The grant will be used to conduct studies in which animals with osteoporosis and vertebral fractures are treated with intravenous injections of human adult stem cells and a hormone already approved by the FDA for the treatment of osteoporosis patients. The study is scheduled to begin in early 2011. Bruce Gewertz, MD, chair of the Department of Surgery and VP for interventional services said, "In the future, innovative application of stem cells will likely be an invaluable tool for surgeons to foster healing in a wide range of musculo-skeletal injuries."

When Spondyloarthritis is more than lower-back pain . . . Chronic lower back pain may be linked to a recently defined form of inflammatory arthritis known as axial spondyloarthritis, according to research presented this week at the ACR annual scientific meeting in Atlanta. Spondyloarthritis is the overall name for a family of inflammatory rheumatic diseases including ankylosing spondylitis that can affect the spine and joints, ligaments and tendons. These diseases can cause fatigue and pain or stiffness in the back, neck, hands, knees, and ankles as well as inflammation of the eyes, skin, lungs, and heart valves. While there is no course of prevention at this time, early treatment by a rheumatologist can reduce discomfort and loss of functionality. Because treatment of spondyloarthritis (including ankylosing spondylitis) may be most successful when the condition is diagnosed early, disease criteria for axial spondyloarthritis that allow for a diagnosis in the absence of radiographic changes have recently been published by the Assessment of Spondyloarthritis International Society, allowing for earlier diagnosis and institution of therapy. Researchers recently set out to determine the prevalence of this rheumatic disease in people being seen by their primary care physicians for chronic lower back pain. Additionally, researchers aimed to assess the value of the clinical tests primary care physicians use to evaluate chronic lower back pain as well as the questionnaires about inflammatory back pain completed by patients when seeking help for this painful condition. The researchers studied 364 primary care patients of whom 43% were male, with an average age of just over 36 years, and who had been experiencing chronic lower back pain symptoms for an average of nine years. Participants were identified through their primary care physician medical records, were asked to complete a questionnaire detailing inflammatory back pain, received a full physical examination by a rheumatologist, and their blood was tested to assess HLAB27 a gene associated with spondyloarthritis and C-reactive protein a blood test of inflammation. The researchers diagnosed 77 participants (21.5%) with axial spondyloarthritis using the ASAS criteria; 52 were diagnosed with an MRI, 28 with X-ray and the presence of one other spondyloarthritis symptom, and 12 were diagnosed with a positive HLAB27 and two other spondyloarthritis symptoms. In all, 6.6% of the participants were diagnosed with the more stringent diagnosis of ankylosing spondylitis, which requires the presence of more advanced X-ray changes. Of the participants seeing their primary care physicians for chronic lower back pain, the prevalence of spondyloarthritis was strikingly high. By using the new ASAS criteria, which aids in early diagnosis and treatment of the disease before structural bone lesions are present, three times as many patients were diagnosed as compared to the currently accepted criteria using conventional X-ray alone. Adding HLAB27 increased the likelihood of diagnosis of spondyloarthritis by 68%, and using X-rays increased the likelihood by 75%.

FDA clears cymbalta to treat chronic musculoskeletal pain . . . The FDA approved Cymbalta (duloxetine hydrochloride), manufactured by Eli Lilly and Co. (Indianapolis) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004. "Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research. "This approval means that many of those people now have another treatment option." Since its initial approval, about 30 million patients in the U.S. have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008. More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing data from the previously approved patient populations. The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo. The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior. While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective.

– Compiled by Holland Johnson, MDD Managing Editor

holland.johnson@ahcmedia.com

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