Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial

Conditions
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Low Back Pain, Mechanical, Complementary Therapies, Progressive Muscle Relaxation

Intervention / Treatment
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* Procedure: Craniosacral Therapy (CST) self-help techniques
* Procedure: Progressive Muscle Relaxation (PMR)


Participation Criteria
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Eligibility Criteria
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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 Simultaneous participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Craniosacral self-help techniques (CST)<br>The experimental group consists of 24 teaching units (TUs) à 45 minutes over 12 weeks. The course starts with an introductory day (8 TUs), followed by 6 practice evenings every two weeks (2 TUs each) and a final afternoon (4 TUs). The patients will also receive a script with theoretical CST basics and descriptions of the techniques, which should facilitate the correct practice at home. | Procedure: Craniosacral Therapy (CST) self-help techniques<br>* Manual self-help techniques based on Craniosacral Therapy (group setting).<br>|
| Active Comparator: Progressive muscle relaxation (PMR)<br>The active control group consists of 24 teaching units (TUs) à 45 minutes over 12 weeks. Every week patients will meet for 2 TUs. The patients will also receive a script with theoretical basics and descriptions of the PMR techniques, hich should facilitate the correct practice at home. | Procedure: Progressive Muscle Relaxation (PMR)<br>* Progressive muscle relaxation according to Jacobsen (group setting).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Impairment | Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Impairment | Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment. | Week 26 | 
| Functional Impairment | Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment. | Week 52 | 
| Pain Intensity | Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain. | Week 12 | 
| Pain Intensity | Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain. | Week 26 | 
| Pain Intensity | Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain. | Week 52 | 
| Health-related Quality of Life | Short Form Health Survey (SF-12): Self-report scale with two subscales (physical and mental qualityy of life). Higher scores indicate better health-related quality of life. | Week 12 | 
| Health-related Quality of Life | Short Form Health Survey (SF-12): Self-report scale with two subscales (physical and mental qualityy of life). Higher scores indicate better health-related quality of life. | Week 26 | 
| Health-related Quality of Life | Short Form Health Survey (SF-12): Self-report scale with two subscales (physical and mental qualityy of life). Higher scores indicate better health-related quality of life. | Week 52 | 
| Severity of Depressive Symptoms | Center for Epidemiologic Studies Depression Scale (CES-D): 10-item self-report short form of the CES-D. Higher scores indicate higher severity of depressive symptoms. | Week 12 | 
| Severity of Depressive Symptoms | Center for Epidemiologic Studies Depression Scale (CES-D): 10-item self-report short form of the CES-D. Higher scores indicate higher severity of depressive symptoms. | Week 26 | 
| Severity of Depressive Symptoms | Center for Epidemiologic Studies Depression Scale (CES-D): 10-item self-report short form of the CES-D. Higher scores indicate higher severity of depressive symptoms. | Week 52 | 
| Severity of Anxious Symptoms | Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms. | Week 12 | 
| Severity of Anxious Symptoms | Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms. | Week 26 | 
| Severity of Anxious Symptoms | Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms. | Week 52 | 
| Global Improvement | Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse. | Week 12 | 
| Global Improvement | Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse. | Week 26 | 
| Global Improvement | Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse. | Week 52 | 
| Number of Patients with Adverse Events | Number of Patients with Adverse Events | Week 12 | 
| Total Number (and Type) of Adverse Events | Total Number (and Type) of Adverse Events | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniosacral Therapy, Low Back Pain, Chronic, Randomized Controlled Trial, Self-help