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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Manual self-help techniques based on Craniosacral Therapy (group setting).
Progressive muscle relaxation according to Jacobsen (group setting).
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Essen, North Rhine-Westphalia, Germany
Functional Impairment
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Time frame: Week 12
Functional Impairment
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Time frame: Week 26
Functional Impairment
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Time frame: Week 52
Pain Intensity
Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Time frame: Week 12
Pain Intensity
Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Time frame: Week 26
Pain Intensity
Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 52
Number of Patients with Adverse Events
Number of Patients with Adverse Events
Time frame: Week 12
Total Number (and Type) of Adverse Events
Total Number (and Type) of Adverse Events
Time frame: Week 12
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