Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain (CRANIO4ME)

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

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 Overview

• Status: Recruiting
• Conditions: Low Back Pain, Mechanical; Complementary Therapies; Progressive Muscle Relaxation
• Intervention / Treatment: Procedure: Craniosacral Therapy (CST) self-help techniques; Procedure: Progressive Muscle Relaxation (PMR)

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Cramer, PhD; Email: holger.cramer@med.uni-tuebingen.de
• Study Contact Backup: Name: Heidemarie Haller, PhD; Phone Number: +4920172377384; Email: heidemarie.haller@uk-essen.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45130
      • Recruiting
      • Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
      • Contact: Heidemarie Haller, PhD; Phone Number: +4920172377384; Email: heidemarie.haller@uk-essen.de
      • Contact: Theresa Dührung; Email: theresa.duering@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Craniosacral self-help techniques (CST); 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; Manual self-help techniques based on Craniosacral Therapy (group setting).
Active Comparator: Progressive muscle relaxation (PMR); 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); Progressive muscle relaxation according to Jacobsen (group setting).

What is the study measuring?

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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Interview	Semi-structured interview based on body image & pain drawings (at week 1 and 12)	Week 12
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
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
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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Study Director: Gustav Dobos, Prof. MD, Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Self-help; Craniosacral Therapy; Low Back Pain, Chronic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 19-8759-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No