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

Low Back Pain, Mechanical Clinical Trial

— CRANIO4ME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199091
• Other study ID #: 19-8759-BO
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: Universität Duisburg-Essen
• Contact: Heidemarie Haller, PhD
• Phone: +4920172377384
• Email: heidemarie.haller[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: October 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Craniosacral Therapy (CST) self-help techniques
Manual self-help techniques based on Craniosacral Therapy (group setting).
• Progressive Muscle Relaxation (PMR)
Progressive muscle relaxation according to Jacobsen (group setting).

Locations

Country	Name	City	State
Germany	Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Awareness	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.	Week 12
Other	Body Awareness	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.	Week 26
Other	Body Awareness	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.	Week 52
Other	Fear-related Avoidance Beliefs	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.	Week 12
Other	Fear-related Avoidance Beliefs	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.	Week 26
Other	Fear-related Avoidance Beliefs	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.	Week 52
Other	Pain Acceptance	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.	Week 12
Other	Pain Acceptance	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.	Week 26
Other	Pain Acceptance	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.	Week 52
Other	Use of Pain Medication	The amount of pain medication during the active study period will be assessed by Defined Daily Doses (DDD) via a diary.	Week 1-12
Other	Freuqnecy of Homework	The total time of performed homework (CST or PMR) during the active study period will be assessed via a diary.	Week 1-12
Other	Treatment Expectations	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.	Week 1
Other	Treamtent Credibility	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.	Week 12
Other	Therapist-Patient-Relationship	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.	Week 12
Other	Interview	Semi-structured interview based on body image & pain drawings (at week 1 and 12)	Week 12
Other	Craniosacral-specific Quality of Life	Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life.	Week 12
Other	Craniosacral-specific Quality of Life	Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life.	Week 26
Other	Craniosacral-specific Quality of Life	Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life.	Week 52
Primary	Functional Impairment	Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.	Week 12
Secondary	Functional Impairment	Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.	Week 26
Secondary	Functional Impairment	Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.	Week 52
Secondary	Pain Intensity	Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.	Week 12
Secondary	Pain Intensity	Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.	Week 26
Secondary	Pain Intensity	Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.	Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Patients with Adverse Events	Number of Patients with Adverse Events	Week 12
Secondary	Total Number (and Type) of Adverse Events	Total Number (and Type) of Adverse Events	Week 12