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Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035399
First Posted: May 6, 2002
Last Update Posted: August 12, 2008
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.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
Intervention Model: Parallel Assignment
Masking: Double
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 Integrative Health (NCCIH):

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

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: John T. Farrar, MD, PhD University of Pennsylvania
  More Information

Responsible Party: John T. Farrar, MD, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00035399     History of Changes
Other Study ID Numbers: R01AT000304-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2002
First Posted: May 6, 2002
Last Update Posted: August 12, 2008
Last Verified: August 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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