Qigong Therapy for Individuals With Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00104156
First received: February 23, 2005
Last updated: January 23, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: External Qigong therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Qigong Therapy for Osteoarthritis at Knees

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Pain, stiffness, and physical function scale results

Secondary Outcome Measures:
  • McGill Pain Questionnaire (MPQ-SF) results
  • Spielberger State-Trait Anxiety Scale (STAI) results
  • Daily dosage of drugs for pain relief
  • Range of motion for knees
  • Time to walk 50 feet

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104156

Locations
United States, New Jersey
University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
Newark, New Jersey, United States, 07103
University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104156     History of Changes
Other Study ID Numbers: R21 AT001352-01A2
Study First Received: February 23, 2005
Last Updated: January 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Knee pain
Arthritis
Qigong
Qi
Meditation
Breathing Exercises

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 26, 2014