Tai Chi for Knee OA Pain Management: a Mechanistic Study

Knee Osteoarthritis Clinical Trial

Official title:

Tai Chi for Pain Management of Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04046003
• Other study ID #: Tai Chi for Knee OA pain
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Mind-body Exercise
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endocannabinoid	plasma endocannabinoid levels	Changes from bseline endocannabinoid levels at 8 weeks
Primary	oxylipins	plasma oxylipins levels	Changes from baseline oxylipins levels at 8 weeks
Secondary	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
Secondary	BDNF	plasma brain-derived neurotrophic factor levels using ELISA	Changes from baseline BDNF levels at 8 weeks
Secondary	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; ?eld 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
Secondary	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
Secondary	Pain assessment	We will use Brief Pain Inventory (questionnaire) for pain assessment.	Change from baseline pain scale at 8 weeks
Secondary	physical function	We will use WOAMC questionnaire for physical function assessment	Changes from baseline WOMAC results at 8 weeks
Secondary	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