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Completed

NCT Number: NCT04199091

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

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.

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Key information

Conditions

Low Back Pain, Mechanical Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Complementary Therapies Graft vs Host Disease Immune System Diseases Low Back Pain Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Progressive Muscle Relaxation Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Essen, North Rhine-Westphalia, 45130, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Craniosacral Therapy (CST) self-help techniques

Procedure

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

Progressive Muscle Relaxation (PMR)

Procedure

Progressive muscle relaxation according to Jacobsen (group setting).

Primary outcomes

  1. Functional Impairment

    Time frame: Week 12

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

Secondary outcomes

  1. Functional Impairment

    Time frame: Week 26

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

  2. Functional Impairment

    Time frame: Week 52

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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Number of Patients with Adverse Events

    Time frame: Week 12

    Number of Patients with Adverse Events

  19. Total Number (and Type) of Adverse Events

    Time frame: Week 12

    Total Number (and Type) of Adverse Events

Other outcomes

  1. Body Awareness

    Time frame: Week 12

    Body Responsiveness Questionnaire (BRQ): 7-iten self-report scale with 3 subscales (Importance of Interoceptive Awareness, Perceived Connection, Suppression of Bodily Sensations). Higher scores indicate higher body awareness on the two subscales Importance of Interoceptive Awareness and Perceived Connection, while higher scores indicate lower body awareness on the subscale Suppression of Bodily Sensations.

  2. Body Awareness

    Time frame: Week 26

    Body Responsiveness Questionnaire (BRQ): 7-iten self-report scale with 3 subscales (Importance of Interoceptive Awareness, Perceived Connection, Suppression of Bodily Sensations). Higher scores indicate higher body awareness on the two subscales Importance of Interoceptive Awareness and Perceived Connection, while higher scores indicate lower body awareness on the subscale Suppression of Bodily Sensations.

  3. Body Awareness

    Time frame: Week 52

    Body Responsiveness Questionnaire (BRQ): 7-iten self-report scale with 3 subscales (Importance of Interoceptive Awareness, Perceived Connection, Suppression of Bodily Sensations). Higher scores indicate higher body awareness on the two subscales Importance of Interoceptive Awareness and Perceived Connection, while higher scores indicate lower body awareness on the subscale Suppression of Bodily Sensations.

  4. Fear-related Avoidance Beliefs

    Time frame: Week 12

    Fear Avoidance Belief Questionnaire (FABQ): 16-item self-report scale with two subscales (fear-avoidance beliefs about physical activity and fear-avoidance beliefs about work). Higher scores indicate higher fear-avoidance beliefs.

  5. Fear-related Avoidance Beliefs

    Time frame: Week 26

    Fear Avoidance Belief Questionnaire (FABQ): 16-item self-report scale with two subscales (fear-avoidance beliefs about physical activity and fear-avoidance beliefs about work). Higher scores indicate higher fear-avoidance beliefs.

  6. Fear-related Avoidance Beliefs

    Time frame: Week 52

    Fear Avoidance Belief Questionnaire (FABQ): 16-item self-report scale with two subscales (fear-avoidance beliefs about physical activity and fear-avoidance beliefs about work). Higher scores indicate higher fear-avoidance beliefs.

  7. Pain Acceptance

    Time frame: Week 12

    Chronic Pain Acceptance Questionnaire (CPAQ): 20-item self-report scale one sumscale and two subscales (activity engagement and pain willingness). Higher schroes indicate higher pain acceptance.

  8. Pain Acceptance

    Time frame: Week 26

    Chronic Pain Acceptance Questionnaire (CPAQ): 20-item self-report scale one sumscale and two subscales (activity engagement and pain willingness). Higher schroes indicate higher pain acceptance.

  9. Pain Acceptance

    Time frame: Week 52

    Chronic Pain Acceptance Questionnaire (CPAQ): 20-item self-report scale one sumscale and two subscales (activity engagement and pain willingness). Higher schroes indicate higher pain acceptance.

  10. Use of Pain Medication

    Time frame: Week 1-12

    The amount of pain medication during the active study period will be assessed by Defined Daily Doses (DDD) via a diary.

  11. Freuqnecy of Homework

    Time frame: Week 1-12

    The total time of performed homework (CST or PMR) during the active study period will be assessed via a diary.

  12. Treatment Expectations

    Time frame: Week 1

    Treatment Credibility Scale (TCS): 1-item self-report numeric rating subscale of the TCS ("Are you confident this treatment will alleviate the pain you feel?") from 0=totally disagree to 10=totally agree. Higher scores indicate higher treamtent expectations.

  13. Treamtent Credibility

    Time frame: Week 12

    Treatment Credibility Scale (TCS): 3-item self-report numeric rating subscale of the TCS from 0=totally disagree to 10=totally agree. Higher scores indicate higher treamtent credibility.

  14. Therapist-Patient-Relationship

    Time frame: Week 12

    Helping Alliance Questionnaire (HAQ): 11-item self-report scale with two subscales (quality of the therapeutic relation and satisfaction with the treatment). Higher scores indicate a higher quality of the therapeutic relation / a higher satisfaction.

  15. Interview

    Time frame: Week 12

    Semi-structured interview based on body image & pain drawings (at week 1 and 12)

  16. Craniosacral-specific Quality of Life

    Time frame: Week 12

    Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life.

  17. Craniosacral-specific Quality of Life

    Time frame: Week 26

    Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life.

  18. Craniosacral-specific Quality of Life

    Time frame: Week 52

    Warwick Holistic Health Questionnaire (WHHQ): 25-item scale ranging from 0 to 100 points. Higher scores indicate higher craniosacral-specific quality of life.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: CRANIO4ME

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2019
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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