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

NCT ID: NCT04199091

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-09-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Craniosacral Therapy (CST) self-help techniques

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Progressive Muscle Relaxation (PMR)

Intervention Type: PROCEDURE

Progressive muscle relaxation according to Jacobsen (group setting).

Interventions

Craniosacral Therapy (CST) self-help techniques

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

Intervention Type: PROCEDURE

Progressive Muscle Relaxation (PMR)

Progressive muscle relaxation according to Jacobsen (group setting).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Heidemarie Haller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

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

Locations

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

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

19-8759-BO

Identifier Type: -

Identifier Source: org_study_id