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临床试验/NCT04046003
NCT04046003已完成不适用

Tai Chi for Pain Management of Knee Osteoarthritis

Texas Tech University Health Sciences Center2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
endocannabinoid

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

endocannabinoid

时间窗: Changes from bseline endocannabinoid levels at 8 weeks

plasma endocannabinoid levels

oxylipins

时间窗: Changes from baseline oxylipins levels at 8 weeks

plasma oxylipins levels

次要结局

  • endocannabinoid receptors expression(Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks)
  • physical function(Changes from baseline WOMAC results at 8 weeks)
  • Pain assessment(Change from baseline pain scale at 8 weeks)
  • BDNF(Changes from baseline BDNF levels at 8 weeks)
  • white matter connectivity/efficiency of various fiber tracts in the brain(Change from baselinewhite matter connectivity/efficiency of various fiber tracts in the brain at 8 weeks)
  • Quality of life assessment(Changes from baseline SF-36 results at 8 weeks)
  • pain sensitivity(Change from baseline pain sensitivity scale at 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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