Clinical trial NCT00417313: Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
Official title: Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: knee pain
acupuncture /acupressure
alternative medicine
analgesia
arthritis therapy
chronic pain
functional ability
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2007-01-01
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes:
measure: changes in physical performance
measure: psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
measure: sleep and appetite
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Pain Evaluattion and Treatment Institute, Research Department
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Debra K Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References: