Tai Chi for Knee OA Pain Management: a Mechanistic Study

Tai Chi for Pain Management of Knee Osteoarthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Mind-body Exercise
• Intervention / Treatment: Behavioral: Tai chi exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi intervention; 24-form Yang style Tai Chi	Behavioral: Tai chi exercise; 24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endocannabinoid	plasma endocannabinoid levels	Changes from bseline endocannabinoid levels at 8 weeks
oxylipins	plasma oxylipins levels	Changes from baseline oxylipins levels at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endocannabinoid receptors expression	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).	Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks
BDNF	plasma brain-derived neurotrophic factor levels using ELISA	Changes from baseline BDNF levels at 8 weeks
white matter connectivity/efficiency of various fiber tracts in the brain	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.	Change from baselinewhite matter connectivity/efficiency of various fiber tracts in the brain at 8 weeks
pain sensitivity	We will use quantitative sensory test including windup to assess pain sensitivity in the most painful knee of subject	Change from baseline pain sensitivity scale at 8 weeks
Pain assessment	We will use Brief Pain Inventory (questionnaire) for pain assessment.	Change from baseline pain scale at 8 weeks
physical function	We will use WOAMC questionnaire for physical function assessment	Changes from baseline WOMAC results at 8 weeks
Quality of life assessment	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.	Changes from baseline SF-36 results at 8 weeks

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Chwan-Li Shen, Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Tai Chi for Knee OA pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No