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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04199091
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2023-08-01
• Primary Completion: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Craniosacral self-help techniques (CST)	Craniosacral Therapy (CST) self-help techniques	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.
Progressive muscle relaxation (PMR)	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.

Primary Outcome Measures

Name	Time	Method
Functional Impairment	Week 12	Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.

Secondary Outcome Measures

Name	Time	Method
Total Number (and Type) of Adverse Events	Week 12	Total Number (and Type) of Adverse Events
Global Improvement	Week 52	Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse.
Severity of Depressive Symptoms	Week 52	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 52	Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
Health-related Quality of Life	Week 52	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.
Functional Impairment	Week 52	Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Pain Intensity	Week 52	Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Number of Patients with Adverse Events	Week 12	Number of Patients with Adverse Events

Trial Locations

Locations (1)

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen; 🇩🇪 Essen, NRW, Germany