Tai Chi and Physical Therapy for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
研究概览
简要总结
We will conduct a large randomized controlled trial comparing the effectiveness and cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for Knee Osteoarthritis.
详细描述
Osteoarthritis (OA) causes pain and long-term disability, and the public health impact will increase as the population ages. In addition to inconsistent effectiveness, current treatments such as nonsteroidal anti-inflammatory drugs, knee replacement, and physical therapy may be expensive, result in serious adverse effects, reduce physical function, and fail to improve mental well-being. Finding effective treatments to maintain function and quality of life in OA patients is one of the national priorities identified this year by the Institute of Medicine.
We propose to conduct the first comparative effectiveness and cost-effectiveness trial of Tai Chi vs. physical therapy (PT) in a large symptomatic Knee OA population. A single-blind, randomized, controlled trial of Tai Chi vs. Physical Therapy will be conducted in 180 patients who meet the American College of Rheumatology criteria for Knee OA. Patients will be randomized to 12 weeks of treatment with Tai Chi (2x/week) or Standard Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorous supervised home exercise) with 24 and 52 week follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years and older
- •American College of Rheumatology criteria for symptomatic Knee OA: Pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade I-III tibiofemoral or patellofemoral OA: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101
- •WOMAC pain subscale score >= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each)
- •Clinical examination confirming knee pain or discomfort or instability referable to the knee joint
- •Physically able to participate in both the Tai Chi and Standard PT programs
- •Willing to undergo testing and intervention procedures and 1.willing to abstain from Tai Chi until completion of the program, if randomized to Standard PT regimen.
- •willing to abstain from Standard PT regimen until completion of the program, if randomized to Tai Chi
排除标准
- •Prior experience with physical therapy, Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi.
- •Serious medical conditions limiting the ability and safety to participate in either the Tai Chi or Standard PT regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia
- •Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee
- •Any intra-articular Synvisc or Hyalgan injections in the previous 6 months
- •Inability to pass the Mini-Mental Status examination (with a score below 24)102
- •Inability to walk without a cane or other assistive device 100% of the time during the baseline assessments
- •Enrollment in any other clinical trial within the last 30 days
- •Plan to permanently relocate from the region during the trial period
- •Positive pregnancy test or planning pregnancy within the study period
- •Not English-Speaking
结局指标
主要结局
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
时间窗: From Week 0 to Week 12
The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
次要结局
- Change in Medical Outcomes Short Form-36 PCS(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in 6 Minute Walk(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in 20 Meter Walk Test(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in Patient Global VAS(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in Beck II Depression Inventory(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in Arthritis Self-Efficacy Scale(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)(From Week 0, to Week 12, or to week 24, or to week 52)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function(From Week 0, to Week 12, or to week 24, or to week 52)
- Outcome Expectation Scale(Week 0)
- Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale(From Week 0, to week 24 or to week 52)