Qigong Therapy for Individuals With Knee Osteoarthritis

NCT ID: NCT00104156

Last Updated: 2008-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-08-31

Brief Summary

The purpose of this study is to evaluate the effectiveness of Qigong therapy, an ancient Chinese practice, for pain relief and symptom improvement in people with knee osteoarthritis (OA).

Study hypotheses: 1) Qigong therapy will result in greater reduction of pain and greater symptom improvement than sham treatment. 2) Individuals with a history of complementary and alternative medicine (CAM) use will be more likely to experience benefits of Qigong therapy than those without such experience.

Detailed Description

OA is the leading cause of disability in the United States. Standard treatment for OA is drug therapy; however, cost, side effects, and varying levels of effectiveness warrant the need for development of new treatments. Qigong therapy, which involves deep meditation, breathing exercises, and the harnessing of energy, may be an effective treatment for OA.

According to traditional Chinese medicine, Qi (Chi) is the "life force" that flows through the body and keeps people healthy and vital. In the practice of traditional Chinese medicine, arthritis is thought to be due to a blockage of the flow of Qi or a buildup of abnormal or damaging Qi. It is believed that releasing this buildup or breaking the blockage of Qi through Qigong therapy may relieve OA symptoms.

Participants will be randomly assigned to receive five sessions of either Qigong therapy or sham treatment over a period of 2 weeks. During Qigong therapy, a therapist will send his or her Qi to the arthritic knees through touch and meditation. Similar body work will be performed during the sham treatment, but no Qi will be harnessed. Self-report scales that measure pain, stiffness, anxiety, daily drug use, CAM use, and overall functioning will be used to assess participants. The assessments will occur at study start and at a 3-month follow-up visit.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

External Qigong therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of osteoarthritis at least 6 months prior to study entry
• Able to understand English

Exclusion Criteria

• Inflammatory joint disease affecting leg movement
• Knee replacement surgery on the OA knee
• Depo-corticosteroid knee injections within 3 months prior to study entry
• Pain in hips or lower back affecting leg movement
• New arthritis drugs or other painkillers within 2 weeks prior to study entry
• Investigational drugs within 30 days prior to study entry
• Asthma requiring oral corticosteroids within 4 weeks prior to study entry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Kevin W. Chen, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Division of Addiction Psychiatry, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

Leonard Sigal, MD

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Department - Biomedical Sciences Program, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

Locations

University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

Newark, New Jersey, United States

University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

Piscataway, New Jersey, United States

Countries

United States

Other Identifiers

R21AT001352-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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