- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104156
Qigong Therapy for Individuals With Knee Osteoarthritis
Qigong Therapy for Osteoarthritis at Knees
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Jersey
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Newark, New Jersey, United States, 07103
- University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
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Piscataway, New Jersey, United States, 08854
- University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pain, stiffness, and physical function scale results
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Secondary Outcome Measures
Outcome Measure |
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Time to walk 50 feet
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McGill Pain Questionnaire (MPQ-SF) results
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Spielberger State-Trait Anxiety Scale (STAI) results
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Daily dosage of drugs for pain relief
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Range of motion for knees
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Collaborators and Investigators
Investigators
- Principal Investigator: Kevin W. Chen, PhD MPH, Division of Addiction Psychiatry, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
- Principal Investigator: Leonard Sigal, MD, Rheumatology Department - Biomedical Sciences Program, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001352-01A2 (U.S. NIH Grant/Contract)
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