Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
Device: periosteal electro-acupuncture (osteopuncture).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability|
- changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index
- changes in physical performance
- psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
- sleep and appetite
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||August 2006|
Knee osteoarthritis (OA) is painful in 6.8% of men and 11.4% of women age 63-93, with over 20 million Americans affected nationwide, and may lead to a variety of untoward consequences including limitations in physical function, postural instability, sleep disturbance, psychosocial disability, and substantial utilization of health care resources. While oral analgesics represent the mainstay of treatment for chronic pain associated with knee OA, non-responders with limiting comorbidities may have few therapeutic alternatives.
The aims of this research study are to (1) reduce pain severity and disability in community-dwelling older adults with OA-associated chronic knee pain using periosteal electroacupuncture (osteopuncture), and (2) improve the physical performance, psychosocial function, sleep, and appetite of these individuals. 88 older adults with persistent knee pain and x-ray evidence of OA, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. All outcome measures for pain and disability, as well as physical performance, psychosocial function, sleep, and appetite, will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417313
|United States, Pennsylvania|
|Pain Evaluattion and Treatment Institute, Research Department|
|Pittsburgh, Pennsylvania, United States, 15206|
|Principal Investigator:||Debra K Weiner, MD||University of Pittsburgh|