Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00035399
First received: May 3, 2002
Last updated: August 11, 2008
Last verified: August 2008
  Purpose

This study will examine the efficacy of acupuncture in combination with exercise physical therapy for moderate osteoarthritis (OA) of the knee.


Condition Intervention Phase
Osteoarthritis
Procedure: Acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 300
Study Start Date: March 2002
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Acupuncture is an ancient Chinese technique of using a fine needle to stimulate points along theoretical meridians of energy to correct imbalances thought to be responsible for specific disease states. In the United States, acupuncture is often used for the treatment of painful conditions. The 1997 NIH Consensus Conference concluded that there was adequate evidence of efficacy in an acute dental pain model and in nausea. In chronic pain, most studies were too small, poorly designed, poorly executed, or improperly controlled to adequately demonstrate that needle acupuncture worked better than sham acupuncture, placebo, standard medical therapy, or even no treatment. Osteoarthritis (OA) of the knee has been proposed as a good model to test the efficacy of acupuncture in a chronic pain condition because it is an extremely common, well defined, and disabling condition with well established outcome measures for symptoms and functional status. There is clinical trial evidence of efficacy for the standard treatments of acetaminophen and NSAIDs, and exercise physical therapy (EPT), which is usually added when the patient develops functional limitations. One high quality study of acupuncture for knee OA, demonstrated moderate benefit in an unblinded comparison to a usual care control group. As such, a major question remains about whether acupuncture, used in addition to exercise therapy, will provide a clinically meaningful improvement in pain and function. Since pain can be the primary limiting factor in improved exercise capacity, if acupuncture has any efficacy in reducing the pain of knee OA, then the combination with an EPT program should be substantially more effective than EPT alone. Another major concern is that the effect of the acupuncture may be predominantly mediated by non- specific placebo effects rather than the specific effects of the placement of a needle. Another important component of this proposal is our use of a validated blinded placebo needle instead of sham acupuncture points. Therefore, the primary goal of this proposal is to use a properly designed randomized blinded clinical trial, using American College of Rheumatology (ACR) criteria and Food and Drug Administration (FDA) recommended outcome measures, to determine whether the addition of acupuncture to standard EPT provides an overall clinically important benefit to patients with symptomatic knee OA compared to placebo acupuncture. As a secondary goal, we will use the clinical trial data to develop prognostic and etiologic models for the patients that are most likely to respond to acupuncture. If a clinically important benefit for acupuncture is found, a broader application of this technique would be justified. However, if the results are negative, then the addition of acupuncture to EPT should be generally curtailed.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • X-ray proven osteoarthritis of the knee - Kellgren level 2 or greater
  • More than 3 months of moderate knee pain
  • Previous trial of NSAIDs or acetaminophen
  • Physician referral for at least 6 physical therapy treatments
  • Capacity to understand the requirements of the study and complete questionnaires

    • Average knee pain with movement, 4 or above, during the last week

EXCLUSION CRITERIA

  • Average hip, back, ankle pain is greater than average knee pain (scale 1-10)
  • Back, hip or ankle pain substantially interferes with patient knee assessment
  • History of gout

    • Acupuncture in the last year
    • Moderate or greater hip or ankle pain greater than 3 daily
    • Local corticosteroid injection into the effected knee within the past 4 weeks
    • Hyaluronidase within the past 6 months
    • Bleeding disorder or current use of Coumadin or Heparin
    • Cardiac or pulmonary disease limiting exercise tolerance enough to limit the standard exercise physical therapy
    • History of alcohol or drug abuse within the past 6 months
    • Unable to complete a six minute walk test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035399

Locations
United States, Pennsylvania
Penn Therapy and Fitness
Philadelphia, Pennsylvania, United States, 19104
Veterans Administration Medical Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital Sports Medicine/Rehabilitation Center
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Investigators
Principal Investigator: John T. Farrar, MD, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: John T. Farrar, MD, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00035399     History of Changes
Other Study ID Numbers: R01 AT000304-01A1
Study First Received: May 3, 2002
Last Updated: August 11, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
acupressure /acupuncture
alternative medicine
arthritis therapy
combination therapy
human therapy evaluation
knee
osteoarthritis
physical therapy
chronic pain
clinical trial
functional ability

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

ClinicalTrials.gov processed this record on April 20, 2014