- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00035399
Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis
August 11, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
This study will examine the efficacy of acupuncture in combination with exercise physical therapy for moderate osteoarthritis (OA) of the knee.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Therapy and Fitness
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Philadelphia, Pennsylvania, United States, 19104
- Veterans Administration Medical Center
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Philadelphia, Pennsylvania, United States
- Pennsylvania Hospital Sports Medicine/Rehabilitation Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John T. Farrar, MD, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
May 3, 2002
First Submitted That Met QC Criteria
May 3, 2002
First Posted (Estimate)
May 6, 2002
Study Record Updates
Last Update Posted (Estimate)
August 12, 2008
Last Update Submitted That Met QC Criteria
August 11, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT000304-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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