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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2021

Interventions

  • Procedure: Craniosacral Therapy (CST) self-help techniques
    • Manual self-help techniques based on Craniosacral Therapy (group setting).
  • Procedure: Progressive Muscle Relaxation (PMR)
    • Progressive muscle relaxation according to Jacobsen (group setting).

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Functional Impairment
    • Time Frame: Week 12
    • Roland Morris Disability Questionnaire (RMDQ): Self-report scale from 0 to 24 points with higher scores indicate higher functional impairment.

Secondary Measures

  • Functional Impairment
    • Time Frame: Week 26
    • Roland Morris Disability Questionnaire (RMDQ): Self-report scale from 0 to 24 points with higher scores indicate higher functional impairment.
  • Functional Impairment
    • Time Frame: Week 52
    • Roland Morris Disability Questionnaire (RMDQ): Self-report scale from 0 to 24 points with higher scores indicate higher functional impairment.
  • Pain Intensity
    • Time Frame: Week 12
    • Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
  • Pain Intensity
    • Time Frame: Week 26
    • Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
  • Pain Intensity
    • Time Frame: Week 52
    • Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
  • Health-related Quality of Life
    • Time Frame: Week 12
    • 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.
  • Health-related Quality of Life
    • Time Frame: Week 26
    • 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.
  • Health-related Quality of Life
    • Time Frame: 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.
  • Severity of Depressive Symptoms
    • Time Frame: Week 12
    • 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 Depressive Symptoms
    • Time Frame: Week 26
    • 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 Depressive Symptoms
    • Time Frame: 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
    • Time Frame: Week 12
    • Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
  • Severity of Anxious Symptoms
    • Time Frame: Week 26
    • Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
  • Severity of Anxious Symptoms
    • Time Frame: Week 52
    • Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
  • Global Improvement
    • Time Frame: Week 12
    • Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse.
  • Global Improvement
    • Time Frame: Week 26
    • Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse.
  • Global Improvement
    • Time Frame: 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.
  • Number of Patients with Adverse Events
    • Time Frame: Week 12
    • Number of Patients with Adverse Events
  • Total Number (and Type) of Adverse Events
    • Time Frame: Week 12
    • Total Number (and Type) of Adverse Events

Participating in This Clinical Trial

Inclusion Criteria

  • Chronic non-specific / functional lower back pain for at least 3 months
  • Functional impairment: 9-20 points on the RMDQ
  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universität Duisburg-Essen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heidemarie Haller, Principal Investigator – Universität Duisburg-Essen
  • Overall Official(s)
    • Gustav Dobos, Prof. MD, Study Director, Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
  • Overall Contact(s)
    • Heidemarie Haller, PhD, +4920117425044, h.haller@kem-med.com

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