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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00417313 |
Purpose
The purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Device: periosteal electro-acupuncture (osteopuncture). |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability |
| Estimated Enrollment: | 88 |
| 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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Pain Evaluattion and Treatment Institute, Research Department | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Principal Investigator: | Debra K Weiner, MD | University of Pittsburgh |
More Information
| Study ID Numbers: | AG0073, 5R21AG024288-02 |
| Study First Received: | December 28, 2006 |
| Last Updated: | December 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00417313 History of Changes |
| Health Authority: | United States: Federal Government |
|
knee pain acupuncture /acupressure alternative medicine analgesia |
arthritis therapy chronic pain functional ability |
|
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |