Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 4
- 主要终点
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
研究概览
简要总结
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be block randomized with stratification for site, sex, and race in double blind fashion.
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral symptomatic knee OA based on American College of Rheumatology Clinical criteria
- •Participant reports primary ethnic/race group as either African American or non-Hispanic white
排除标准
- •Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain.
- •A history of clinically significant surgery to the index knee.
- •Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed.
- •Use of some centrally acting sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because some of these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models.
- •Uncontrolled hypertension (i.e. SBP/DBP of > 150/95) or unstable or activity limiting cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons, because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals.
- •Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy) or evidence of previous brain injury, including stroke and traumatic brain injury.
- •Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation.
- •Current substance use disorder or history of hospitalization for treatment of substance use disorder.
- •Diminished cognitive function that would interfere with understanding of study procedures.
结局指标
主要结局
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
时间窗: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = V7 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness.
次要结局
未报告次要终点