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Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
This study has been completed.
Study NCT00417313   Information provided by National Institute on Aging (NIA)
First Received: December 28, 2006   No Changes Posted

December 28, 2006
December 28, 2006
October 2004
 
changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index
Same as current
No Changes Posted
  • changes in physical performance
  • psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
  • sleep and appetite
Same as current
 
Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

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.

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.

Phase II
Interventional
Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Osteoarthritis
Device: periosteal electro-acupuncture (osteopuncture).
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
88
August 2006
 

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00417313
 
AG0073, 5R21AG024288-02
National Institute on Aging (NIA)
 
Principal Investigator: Debra K Weiner, MD University of Pittsburgh
National Institute on Aging (NIA)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP