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Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

This study has been completed.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
Official Title  Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index
Secondary Outcome Measure  changes in physical performance
psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
sleep and appetite
Condition  Osteoarthritis
Intervention  Device: periosteal electro-acupuncture (osteopuncture).
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  88
Start Date  October 2004
Completion Date August 2006
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
Gender Both
Ages 65 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00417313
Organization ID AG0073
Secondary IDs †† 5R21AG024288-02
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Debra K Weiner, MD     University of Pittsburgh    
Information Provided By National Institute on Aging (NIA)
Verification Date December 2006
First Received Date  December 28, 2006
Last Updated Date December 28, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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