Clinical trial NCT04046003: Tai Chi for Knee OA Pain Management: a Mechanistic Study
Official title: Tai Chi for Pain Management of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Mind-body Exercise
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 33
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: endocannabinoid
timeFrame: Changes from bseline endocannabinoid levels at 8 weeks
measure: oxylipins
timeFrame: Changes from baseline oxylipins levels at 8 weeks
Secondary outcomes:
measure: endocannabinoid receptors expression
timeFrame: Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks
measure: BDNF
timeFrame: Changes from baseline BDNF levels at 8 weeks
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
measure: pain sensitivity
timeFrame: Change from baseline pain sensitivity scale at 8 weeks
measure: Pain assessment
timeFrame: Change from baseline pain scale at 8 weeks
measure: physical function
timeFrame: Changes from baseline WOMAC results at 8 weeks
measure: Quality of life assessment
timeFrame: Changes from baseline SF-36 results at 8 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Chwan-Li Shen
role: PRINCIPAL_INVESTIGATOR
References: