Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00417313
First received: December 28, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention Phase
Osteoarthritis
Device: periosteal electro-acupuncture (osteopuncture).
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

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

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

Estimated Enrollment: 88
Study Start Date: October 2004
Estimated Study Completion Date: August 2006
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417313

Locations
United States, Pennsylvania
Pain Evaluattion and Treatment Institute, Research Department
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Investigators
Principal Investigator: Debra K Weiner, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00417313     History of Changes
Other Study ID Numbers: AG0073, 5R21AG024288-02
Study First Received: December 28, 2006
Last Updated: December 28, 2006
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014