Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417313
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : January 1, 2007
Information provided by:
National Institute on Aging (NIA)

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 Type : Interventional  (Clinical Trial)
Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
Study Start Date : October 2004
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index

Secondary Outcome Measures :
  1. changes in physical performance
  2. psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
  3. sleep and appetite

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417313

United States, Pennsylvania
Pain Evaluattion and Treatment Institute, Research Department
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Debra K Weiner, MD University of Pittsburgh Identifier: NCT00417313     History of Changes
Other Study ID Numbers: AG0073
5R21AG024288-02 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: January 1, 2007
Last Verified: December 2006

Keywords provided by National Institute on Aging (NIA):
knee pain
acupuncture /acupressure
alternative medicine
arthritis therapy
chronic pain
functional ability

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases