Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: periosteal electro-acupuncture (osteopuncture).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: periosteal electro-acupuncture (osteopuncture).|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in physical performance |  |  | 
| psychosocial function (mood, self-efficacy, coping, fear, self-rated health) |  |  | 
| sleep and appetite |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee pain, acupuncture /acupressure, alternative medicine, analgesia, arthritis therapy, chronic pain, functional ability