Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain, Mechanical
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Functional Impairment
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Investigators
Heidemarie Haller
Principal Investigator
Universität Duisburg-Essen
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Functional Impairment
Time Frame: Week 12
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Secondary Outcomes
- 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)