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

Completed

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

Interventional

Enrollment

100

Phase

  • Phase 2

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

    • New Jersey
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School
      • Piscataway, New Jersey, United States, 08854
        • University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain, stiffness, and physical function scale results

Secondary Outcome Measures

Outcome Measure
Time to walk 50 feet
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

January 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 23, 2005

First Submitted That Met QC Criteria

February 23, 2005

First Posted (Estimate)

February 24, 2005

Study Record Updates

Last Update Posted (Estimate)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • R21AT001352-01A2 (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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