NCT06903962招募中不适用
Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
研究概览
简要总结
The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow).
- To determine if a mind-body intervention improves upper extremity functional capacity (ie., Disability of Arm Shoulder Hand - DASH) among people with chronic wrist, elbow, and shoulder pain
- To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.
- To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.
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
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years of age)
- •A disability score ≥ 40 as per the QuickDASH survey
- •Presence of pain and perceived disability for a minimum of 3 months
- •Willing to engage in a Mind-Body intervention
- •Positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain)
排除标准
- •Clear organic diagnosis of pain (e.g., cancer, infection, etc…) not inclusive of non-specific findings on imaging studies (e.g., mild arthritis)
- •Age greater than 60 years (due to an increased risk of there being an organic/physical cause for their pain and confounding results)
- •Diagnosis of cognitive impairment or dementia
- •Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
- •Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered in this category
研究组 & 干预措施
Experimental: Mind-body Intervention
Experimental
Mind body techniques for the intervention will be taught in lectures and group discussion sessions
干预措施: Mind-Body Intervention (Behavioral)
结局指标
主要结局
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
时间窗: Baseline, 4 weeks, 8 weeks, 13 weeks
The DASH is a commonly used and validated 38 question survey self-report survey assessing the effects of upper extremity disabling conditions on functional activity, pain, sleep, and other parameters
次要结局
- Upper Extremity Function Scale(Baseline, 4 weeks, 8 weeks, 13 weeks)
- Brief Pain Inventory Questionnaire (Short Form)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- Pain Anxiety Symptom Scale (short form 20)(Baseline, 4 weeks, 8 weeks, 13 weeks)
- Somatic Symptom Score (SSS-8)(Baseline, 4 weeks, 8 weeks, 13 weeks)
研究者
Michael Donnino
Professor of Emergency Medicine
Beth Israel Deaconess Medical Center
研究点 (1)
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