Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 4:52 PM
Study NCT ID:
NCT04046003
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2019-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tai Chi for Knee OA Pain Management: a Mechanistic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088543', 'term': 'Aquatic Therapy'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endocannabinoid', 'timeFrame': 'Changes from bseline endocannabinoid levels at 8 weeks', 'description': 'plasma endocannabinoid levels'}, {'measure': 'oxylipins', 'timeFrame': 'Changes from baseline oxylipins levels at 8 weeks', 'description': 'plasma oxylipins levels'}], 'secondaryOutcomes': [{'measure': 'endocannabinoid receptors expression', 'timeFrame': 'Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks', 'description': 'expression of endocannabinoids receptors on peripheral blood mononuclear cells using flow cytometry. Collect venous blood into evacuated tube containing lithium heparin and pour into a Leucosep tube prepared with Ficoll-Paque. Following sequential centrifugation steps, peripheral blood mononuclear cells will be collected and incubate with endotoxin (e.g. LPS or PMA) for 24 hours (Venable 2016). After incubation, PBMC will be collected and stained with cannabinoid receptors (CB1R and CB2R) and markers for monocytes/macrophages (CD14, etc).'}, {'measure': 'BDNF', 'timeFrame': 'Changes from baseline BDNF levels at 8 weeks', 'description': 'plasma brain-derived neurotrophic factor levels using ELISA'}, {'measure': 'white matter connectivity/efficiency of various fiber tracts in the brain', 'timeFrame': 'Change from baselinewhite matter connectivity/efficiency of various fiber tracts in the brain at 8 weeks', 'description': 'We will follow the protocol of Vachon-Presseau et al. 2006 to collect DTI data. DTI images will be acquired using echo planar imaging (72 x 2-mm thick axial slices; matrix size = 128 x 128; field of view = 256 x 256mm2, resulting in a voxel size of 2 x 2 x 2mm). Images will have an isotropic distribution along 60 directions using a b-value of 1000s/mm2. For each set of diffusion-weighted data, eight volumes with no diffusion weighting will be acquired at equidistant points throughout the acquisition.'}, {'measure': 'pain sensitivity', 'timeFrame': 'Change from baseline pain sensitivity scale at 8 weeks', 'description': 'We will use quantitative sensory test including windup to assess pain sensitivity in the most painful knee of subject'}, {'measure': 'Pain assessment', 'timeFrame': 'Change from baseline pain scale at 8 weeks', 'description': 'We will use Brief Pain Inventory (questionnaire) for pain assessment.'}, {'measure': 'physical function', 'timeFrame': 'Changes from baseline WOMAC results at 8 weeks', 'description': 'We will use WOAMC questionnaire for physical function assessment'}, {'measure': 'Quality of life assessment', 'timeFrame': 'Changes from baseline SF-36 results at 8 weeks', 'description': 'Quality of life status will be assessed with the Medical Outcomes Study 36-item short form Health Survey (SF-36, version 2), which consists of eight dimensions of health (physical function, bodily pain, general health, vitality, mental health, social function, and role of physical and emotional health) in the conduct of daily activity characteristics will be assessed with self-report SF-36 questionnaires related to self-rated health, depression, anxiety and sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Mind-body Exercise']}, 'referencesModule': {'references': [{'pmid': '37654656', 'type': 'DERIVED', 'citation': 'Shen CL, Newman JW, Elmassry MM, Borkowski K, Chyu MC, Kahathuduwa C, Neugebauer V, Watkins BA. Tai Chi exercise reduces circulating levels of inflammatory oxylipins in postmenopausal women with knee osteoarthritis: results from a pilot study. Front Med (Lausanne). 2023 Aug 16;10:1210170. doi: 10.3389/fmed.2023.1210170. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This study is to determine how 8-week Tai Chi intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.', 'detailedDescription': "Knee osteoarthritis (OA) is one of the five leading causes of disability. Previous studies have shown that a mind-body moderate-intensity Tai Chi (TC) exercise (8-24 weeks) reduced pain and improved physical function for knee OA, when compared to a waiting list, attention control, usual physical activity, or physical therapy. However, TC's mechanisms of action regarding improvement of one's clinical condition and its functional outcomes in individuals with knee OA are poorly understood. This study is to determine how 8-week TC intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Postmenopausal women.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Postmenopausal women.\n2. WOMAC pain score ≥ 50 on at least 1 of the 5 questions in pain subscale (range of 0 to 100, with higher scores indicating greater pain.\n3. English literacy.\n4. Able to undergo an MRI scan\n5. Diagnosed Have the following symptoms associated with knee OA based on American College of Rheumatology clinical classification criteria for osteoarthritis (Peat 2006). Pain in the knee. Need to at least 3 of the following: over 50 years of age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth of synovium.\n\nExclusion Criteria:\n\n1. Prior experience with mind-body practice (e.g. TC, Qi Gong, yoga, or acupuncture) or physical therapy programs for knee OA within the past 3 months.\n2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation.\n3. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems (i.e. polio/Parkinson's/multiple sclerosis, etc. in addition to cerebral vascular accident or stroke) and diabetes with peripheral neuropathy affecting their sensory/balance.\n4. Intra-articular steroid injection or reconstructive surgery on most severely affected knee in the past three months.\n5. Intra-articular hyaluronic acid injections on most severely affected knee in the past six months.\n6. Inability to walk without an assistive device."}, 'identificationModule': {'nctId': 'NCT04046003', 'briefTitle': 'Tai Chi for Knee OA Pain Management: a Mechanistic Study', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center'}, 'officialTitle': 'Tai Chi for Pain Management of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'Tai Chi for Knee OA pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi intervention', 'description': '24-form Yang style Tai Chi', 'interventionNames': ['Behavioral: Tai chi exercise']}], 'interventions': [{'name': 'Tai chi exercise', 'type': 'BEHAVIORAL', 'description': '24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks', 'armGroupLabels': ['Tai Chi intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'overallOfficials': [{'name': 'Chwan-Li Shen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}