Complementary Therapies, Low Back Pain, Mechanical, Progressive Muscle Relaxation
Conditions
Keywords
Craniosacral Therapy, Low Back Pain, Chronic, Randomized Controlled Trial, Self-help
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.
Interventions
PROCEDURECraniosacral Therapy (CST) self-help techniques
Manual self-help techniques based on Craniosacral Therapy (group setting).
PROCEDUREProgressive Muscle Relaxation (PMR)
Progressive muscle relaxation according to Jacobsen (group setting).
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Impairment | Week 12 | Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients with Adverse Events | Week 12 | Number of Patients with Adverse Events |
| Functional Impairment | Week 26 | Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment. |
| Pain Intensity | Week 12 | Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain. |
| Total Number (and Type) of Adverse Events | Week 12 | Total Number (and Type) of Adverse Events |
| Severity of Depressive Symptoms | Week 12 | 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. |
| Severity of Anxious Symptoms | Week 12 | Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms. |
| Global Improvement | Week 12 | Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse. |
| Health-related Quality of Life | Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Awareness | Week 12 | Body Responsiveness Questionnaire (BRQ): 7-iten self-report scale with 3 subscales (Importance of Interoceptive Awareness, Perceived Connection, Suppression of Bodily Sensations). Higher scores indicate higher body awareness on the two subscales Importance of Interoceptive Awareness and Perceived Connection, while higher scores indicate lower body awareness on the subscale Suppression of Bodily Sensations. |
| Craniosacral-specific Quality of Life | Week 12 | Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life. |
| Fear-related Avoidance Beliefs | Week 12 | Fear Avoidance Belief Questionnaire (FABQ): 16-item self-report scale with two subscales (fear-avoidance beliefs about physical activity and fear-avoidance beliefs about work). Higher scores indicate higher fear-avoidance beliefs. |
| Pain Acceptance | Week 12 | Chronic Pain Acceptance Questionnaire (CPAQ): 20-item self-report scale one sumscale and two subscales (activity engagement and pain willingness). Higher schroes indicate higher pain acceptance. |
| Use of Pain Medication | Week 1-12 | The amount of pain medication during the active study period will be assessed by Defined Daily Doses (DDD) via a diary. |
| Freuqnecy of Homework | Week 1-12 | The total time of performed homework (CST or PMR) during the active study period will be assessed via a diary. |
| Treatment Expectations | Week 1 | Treatment Credibility Scale (TCS): 1-item self-report numeric rating subscale of the TCS (Are you confident this treatment will alleviate the pain you feel?) from 0=totally disagree to 10=totally agree. Higher scores indicate higher treamtent expectations. |
| Treamtent Credibility | Week 12 | Treatment Credibility Scale (TCS): 3-item self-report numeric rating subscale of the TCS from 0=totally disagree to 10=totally agree. Higher scores indicate higher treamtent credibility. |
| Therapist-Patient-Relationship | Week 12 | Helping Alliance Questionnaire (HAQ): 11-item self-report scale with two subscales (quality of the therapeutic relation and satisfaction with the treatment). Higher scores indicate a higher quality of the therapeutic relation / a higher satisfaction. |
| Interview | Week 12 | Semi-structured interview based on body image & pain drawings (at week 1 and 12) |
Countries
Germany
Outcome results
None listed