Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Functional Impairment
研究概览
简要总结
Craniosacral Therapy (CST) is a non-manipulative, very gentle manual treatment method. Although the mechanisms of action have not yet been investigated sufficiently, initial clinical trials support CST efficacy/effectiveness in chronic pain disorders such as back pain, neck pain, and fibromyalgia. In clinical practice, therapists also report pain alleviating effects of CST self-help techniques, offered to patients within a group concept. Yet, the effectiveness of teaching CST self-help techniques to medical laypersons has not yet been scientifically investigated.
Therefore, this study aims at collecting quantifiable data on the effectiveness and safety of a CST self-help group concept, developed for patients with chronic non-specific low back pain. The intervention group will receive 24 lessons of education and practice in CST self-help techniques over 12 weeks, while the control group will receive the same amount of self-help (education and practice) in progressive muscle relaxation. Six and 12 months after randomization, longer-term effects will be investigated.
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 (Investigator, Outcomes Assessor)
盲法说明
The investigator who will perform the group assignment will have no contact to the study participants. The outcome assessors will be blinded to group allocation. Patients will partly be blinded to the group intervention: The will be told that they will receive one of two self-help therapies - one that focus on the relaxation of fasciae and the other that focus on the relaxation of muscles. The statistician who will perform the analyses will kept blind to the group intervention by renaming groups with numbers.
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
- •Chronic non-specific / functional lower back pain for at least 3 months
- •Functional impairment: minimal 11 and maximal 41 points on the ODI
- •Willingness to participate in the group program and practice at home
排除标准
- •Specific back pain due to:
- •Severe congenital or acute degenerative diseases
- •Severe inflammatory musculoskeletal or rheumatic diseases
- •Neurological diseases
- •Status after actue trauma/whiplash
- •Status after neoplasms in the area of the spinal column
- •Acute severe comorbid mental illness or other acute severe comorbid somatic illness
- •Pregnancy
- •Current pension application
- •Regular use of corticosteroids, opiates, muscle relaxants, or antidepressants
- •Simultaneous participation in other clinical trials
结局指标
主要结局
Functional Impairment
时间窗: Week 12
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
次要结局
- Severity of Depressive Symptoms(Week 52)
- Severity of Anxious Symptoms(Week 52)
- Total Number (and Type) of Adverse Events(Week 12)
- Health-related Quality of Life(Week 52)
- Global Improvement(Week 52)
- Functional Impairment(Week 52)
- Pain Intensity(Week 52)
- Number of Patients with Adverse Events(Week 12)
研究者
Heidemarie Haller
Principal Investigator
Universität Duisburg-Essen