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

NCT04199091 | Completed

• 1 other identifier: 19-8759-BO
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Craniosacral Therapy; Low Back Pain, Chronic; Randomized Controlled Trial; Self-help

Outcome Measures

Primary Outcomes (1)

• Functional Impairment

  Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.

  Week 12

Secondary Outcomes (19)

• Functional Impairment

  Week 26

• Functional Impairment

  Week 52

• Pain Intensity

  Week 12

• Pain Intensity

  Week 26

• Pain Intensity

  Week 52

Other Outcomes (18)

• Body Awareness

  Week 12

• Body Awareness

  Week 26

• Body Awareness

  Week 52

Study Arms (2)

Craniosacral self-help techniques (CST)

EXPERIMENTAL

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

Progressive muscle relaxation (PMR)

ACTIVE COMPARATOR

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)

Interventions

Craniosacral Therapy (CST) self-help techniques PROCEDURE

Manual self-help techniques based on Craniosacral Therapy (group setting).

Craniosacral self-help techniques (CST)

Progressive Muscle Relaxation (PMR) PROCEDURE

Progressive muscle relaxation according to Jacobsen (group setting).

Progressive muscle relaxation (PMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Essen, North Rhine-Westphalia, 45130, Germany

Location

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

galactosylceramide sulfotransferase; Autogenic Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gustav Dobos, Prof. MD

  Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: August 1, 2023
• Primary Completion: January 10, 2025
• Study Completion: September 29, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)