Mind Body Therapy for the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain Disability: Roland Morris Disability Index
研究概览
简要总结
Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.
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
Participants will be partially blinded. Participants in the usual care 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 —（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 ≥3 days/week for the past 3 months prior to enrollment
- •Willingness to consider mind-body intervention
排除标准
- •Patients < 18 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. 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.
结局指标
主要结局
Pain Disability: Roland Morris Disability Index
时间窗: change over 26 weeks
Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst)
次要结局
- Pain-related hospital admissions(26 weeks)
- Pain Bothersomeness: Brief Pain Inventory Survey(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Pain affecting enjoyment of life(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Average Pain: Brief Pain Inventory Survey(4 weeks, 8 weeks, 13, weeks, 26 weeks)
- Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Anxiety from pain: Pain Anxiety Symptom Scale-20 survey(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Complete resolution of pain disability: Roland Morris Disability(4 weeks, 8 weeks, 13 weeks, 26 weeks)
研究者
Michael Donnino
Associate Professor of Emergency Medicine
Beth Israel Deaconess Medical Center