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Completed

NCT Number: NCT04046003

Tai Chi for Knee OA Pain Management: a Mechanistic Study

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Mind-body Exercise Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women.
  • 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.
  • English literacy.
  • Able to undergo an MRI scan
  • 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

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

Treatment and study plan

Tai Chi Exercise

Behavioral

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

Primary outcomes

  1. endocannabinoid

    Time frame: Changes from bseline endocannabinoid levels at 8 weeks

    plasma endocannabinoid levels

  2. oxylipins

    Time frame: Changes from baseline oxylipins levels at 8 weeks

    plasma oxylipins levels

Secondary outcomes

  1. endocannabinoid receptors expression

    Time frame: Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks

    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).

  2. BDNF

    Time frame: Changes from baseline BDNF levels at 8 weeks

    plasma brain-derived neurotrophic factor levels using ELISA

  3. white matter connectivity/efficiency of various fiber tracts in the brain

    Time frame: Change from baselinewhite matter connectivity/efficiency of various fiber tracts in the brain at 8 weeks

    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.

  4. pain sensitivity

    Time frame: Change from baseline pain sensitivity scale at 8 weeks

    We will use quantitative sensory test including windup to assess pain sensitivity in the most painful knee of subject

  5. Pain assessment

    Time frame: Change from baseline pain scale at 8 weeks

    We will use Brief Pain Inventory (questionnaire) for pain assessment.

  6. physical function

    Time frame: Changes from baseline WOMAC results at 8 weeks

    We will use WOAMC questionnaire for physical function assessment

  7. Quality of life assessment

    Time frame: Changes from baseline SF-36 results at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Tai Chi for Pain Management of Knee Osteoarthritis

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2019
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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