Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
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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 2 |
| Study Type: | Interventional |
| 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
| 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:
- Radiographic evidence of knee OA on a standing AP X-ray
- Bilateral knee pain for at least 3 months with pain of at least moderate intensity every day or almost every day
Exclusion Criteria:
- Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker)
- Folstein Mini-Mental State Examination score of less than 24
- Severe visual or hearing impairment
- Knee pain due to factors other than OA, e.g. rheumatoid or psoriatic arthritis, gout, pseudogout, metastatic cancer
- Significant pain in parts of the body other than the knee or acute knee pain
- A large knee effusion or severe mechanical instability of the knee
- History of corticosteroid injection in the affected knee(s) during the preceding 3 months
- History of hyaluronic acid injection in the affected knee(s) during the preceding 3 months
- Acute or terminal illness
- Immune suppression
- Anticoagulation therapy
- Presence of a pacemaker
- Prior acupuncture treatment
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00417313 History of Changes |
| Other Study ID Numbers: | AG0073, 5R21AG024288-02 |
| Study First Received: | December 28, 2006 |
| Last Updated: | December 28, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
knee pain acupuncture /acupressure alternative medicine analgesia |
arthritis therapy chronic pain functional ability |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013