Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

NCT ID: NCT00417313

Last Updated: 2007-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-08-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

periosteal electro-acupuncture (osteopuncture).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: lead

Principal Investigators

Debra K Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Pain Evaluattion and Treatment Institute, Research Department

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

5R21AG024288-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0073

Identifier Type: -

Identifier Source: org_study_id