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

Universität Duisburg-Essen

Status: Completed

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

Treatments: Procedure: Progressive Muscle Relaxation (PMR); Procedure: Craniosacral Therapy (CST) self-help techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT04199091

19-8759-BO

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Craniosacral self-help techniques (CST)

Experimental group

Description:

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.

Treatment:

Procedure: Craniosacral Therapy (CST) self-help techniques

Progressive muscle relaxation (PMR)

Active Comparator group

Description:

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.

Treatment:

Procedure: Progressive Muscle Relaxation (PMR)