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Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00417313
Enrollment
88
Registered
2007-01-01
Start date
2004-10-31
Completion date
2006-08-31
Last updated
2007-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

knee pain, acupuncture /acupressure, alternative medicine, analgesia, arthritis therapy, chronic pain, functional ability

Brief summary

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

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.

Interventions

DEVICEperiosteal electro-acupuncture (osteopuncture).

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index

Secondary

MeasureTime frame
changes in physical performance
psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
sleep and appetite

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026