Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00417313

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: periosteal electro-acupuncture (osteopuncture).	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Study Start Date :

Oct 1, 2004

Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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