Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00104156
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2005-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Qigong Therapy for Individuals With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-23', 'studyFirstSubmitDate': '2005-02-23', 'studyFirstSubmitQcDate': '2005-02-23', 'lastUpdatePostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, stiffness, and physical function scale results'}], 'secondaryOutcomes': [{'measure': 'McGill Pain Questionnaire (MPQ-SF) results'}, {'measure': 'Spielberger State-Trait Anxiety Scale (STAI) results'}, {'measure': 'Daily dosage of drugs for pain relief'}, {'measure': 'Range of motion for knees'}, {'measure': 'Time to walk 50 feet'}]}, 'conditionsModule': {'keywords': ['Knee pain', 'Arthritis', 'Qigong', 'Qi', 'Meditation', 'Breathing Exercises'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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).\n\nStudy 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.', 'detailedDescription': '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.\n\nAccording 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of osteoarthritis at least 6 months prior to study entry\n* Able to understand English\n\nExclusion Criteria:\n\n* Inflammatory joint disease affecting leg movement\n* Knee replacement surgery on the OA knee\n* Depo-corticosteroid knee injections within 3 months prior to study entry\n* Pain in hips or lower back affecting leg movement\n* New arthritis drugs or other painkillers within 2 weeks prior to study entry\n* Investigational drugs within 30 days prior to study entry\n* Asthma requiring oral corticosteroids within 4 weeks prior to study entry'}, 'identificationModule': {'nctId': 'NCT00104156', 'briefTitle': 'Qigong Therapy for Individuals With Knee Osteoarthritis', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Qigong Therapy for Osteoarthritis at Knees', 'orgStudyIdInfo': {'id': 'R21AT001352-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001352-01A2', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'External Qigong therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Kevin W. Chen, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Addiction Psychiatry, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School'}, {'name': 'Leonard Sigal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rheumatology Department - Biomedical Sciences Program, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}