Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Functional status, Roland Morris Scale
研究概览
简要总结
Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.
详细描述
Focus Patients with back pain often demonstrate symptoms of PTSD measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each other.
Methods Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center are screened for PTSD. It is expected that 100 patients will meet the inclusion criteria and be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Conclusion The project started in 2013, so there have not yet been any results. Currently total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm.
Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months.
This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Back pain: from 1/2 Y duration or longer
- •Trauma according to HTQ
排除标准
- 未提供
研究组 & 干预措施
Standard back pain treatment
Standard back pain treatment
干预措施: Standard back pain treatment (Other)
standard + 10 psychotherapeutic sessions
- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
干预措施: Standard back pain treatment + 10 psychotherapeutic sessions (Other)
结局指标
主要结局
Functional status, Roland Morris Scale
时间窗: 0, 1 year
scale ranging from 0-24
次要结局
- Back pain intensity, numeric rating scale(0, 1 year)
- Harvard Trauma Questionnaire(0, 1 year)
研究者
Tonny Elmose Andersen, phd.
associate professor
University of Southern Denmark