Tai Chi for Knee OA Pain Management: a Mechanistic Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Postmenopausal women. 2. 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. 3. English literacy. 4. Able to undergo an MRI scan. 5. 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.

Exclusion Criteria:

1. 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. 2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation. 3. 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. 4. Intra-articular steroid injection or reconstructive surgery on most severely affected knee in the past three months. 5. Intra-articular hyaluronic acid injections on most severely affected knee in the past six months. 6. Inability to walk without an assistive device.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04046003
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Texas Tech University Health Sciences Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chwan-Li Shen
Principal Investigator Affiliation	Texas Tech University Health Sciences Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis, Mind-body Exercise

Additional Details

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.

Arms & Interventions

Arms

Experimental: Tai Chi intervention

24-form Yang style Tai Chi

Interventions

Behavioral: - Tai chi exercise

24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lubbock, Texas

Status

Recruiting

Address

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430

Site Contact

Chwan-Li (Leslie) Shen, PhD

[email protected]

806-743-2815

Clinical Trial Finder