Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00035399

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

100

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Procedure: Acupuncture	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Penn Therapy and Fitness	Philadelphia	Pennsylvania	United States	19104
2	Veterans Administration Medical Center	Philadelphia	Pennsylvania	United States	19104
3	Pennsylvania Hospital Sports Medicine/Rehabilitation Center	Philadelphia	Pennsylvania	United States