Mind Body Syndrome Therapy for the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain Disability
研究概览
简要总结
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
详细描述
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Participants in Mind-Body Intervention 2 arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient 18 ≥ years old
- •Chronic back pain
- •Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
- •Willingness to consider mind-body intervention
- •At least score of 2 or more on Roland Disability Questionnaire
- •At least score of 3 or more back pain bothersomeness
排除标准
- •Patients < 18 years of age
- •Patients > 67 years of age
- •Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments)
- •Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder
研究组 & 干预措施
Mind-Body Intervention 1
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
干预措施: Mind Body Intervention 1 (Behavioral)
Mind-Body Intervention 2
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.
干预措施: Mind body intervention 2 (Behavioral)
Usual Care
Participants will continue their usual care for 26 weeks
结局指标
主要结局
Pain Disability
时间窗: 26 weeks
Roland Morris Disability Index (Scale 0-24 with 24 being worst)
次要结局
- Anxiety from pain(Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Average pain(Baseline, 4, 8, 13, and 26 weeks after initiation of the study.)
- Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey(Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Pain affecting enjoyment of life(Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Resolution of pain disability(Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Resolution of back pain bothersomeness(Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks)
研究者
Michael Donnino
Associate Professor of Emergency Medicine
Beth Israel Deaconess Medical Center