Low Back Pain, MechanicalCRANIO4MENCT04199091
Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain
A study testing Craniosacral Therapy (CST) self-help techniques and Progressive Muscle Relaxation (PMR) in people with Low Back Pain, Mechanical and Complementary Therapies, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical, Complementary Therapies, Progressive Muscle Relaxation
- What is being tested?
- Craniosacral Therapy (CST) self-help techniques and Progressive Muscle Relaxation (PMR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2023to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Essen, North Rhine-Westphalia, 45130
About this study
Official title: Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial
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.
- Being tested
- Craniosacral Therapy (CST) self-help techniques, Progressive Muscle Relaxation (PMR)
- Keywords
- Craniosacral Therapy, Low Back Pain, Chronic, Randomized Controlled Trial, Self-help
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral Therapy (CST) self-help techniquesProcedure or surgery
Manual self-help techniques based on Craniosacral Therapy (group setting).
Progressive Muscle Relaxation (PMR)Procedure or surgery
Progressive muscle relaxation according to Jacobsen (group setting).
| Study group | Role | What they receive |
|---|---|---|
| Craniosacral self-help techniques (CST) | Experimental | 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. Receives: Procedure: Craniosacral Therapy (CST) self-help techniques |
| Progressive muscle relaxation (PMR) | Active comparator | 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. Receives: Procedure: Progressive Muscle Relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Impairment
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Measured: Week 12
Secondary outcomes (19)
Functional Impairment
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Measured: Week 26
Functional Impairment
Oswestry Disability Index (ODI): Self-report scale from 0 to 50 points with higher scores indicate higher functional impairment.
Measured: Week 52
Pain Intensity
Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Measured: Week 12
Pain Intensity
Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Measured: Week 26
Pain Intensity
Numeric rating scale (NRS): Self-report scale from 0-10 points with 0=no pain and 10=worst pain.
Measured: Week 52
Health-related Quality of Life
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.
Measured: Week 12
Health-related Quality of Life
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.
Measured: Week 26
Health-related Quality of Life
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.
Measured: Week 52
Severity of Depressive Symptoms
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.
Measured: Week 12
Severity of Depressive Symptoms
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.
Measured: Week 26
Severity of Depressive Symptoms
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.
Measured: Week 52
Severity of Anxious Symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
Measured: Week 12
Severity of Anxious Symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
Measured: Week 26
Severity of Anxious Symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS): 7-item self-report anxiety subscale. Higher scores indicate higher severity of anxious symptoms.
Measured: Week 52
Global Improvement
Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse.
Measured: Week 12
Global Improvement
Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse.
Measured: Week 26
Global Improvement
Patient Global Impression of Improvement Scale (PGI-I): 7-point self-report scale from 1=very much improved to 7=very much worse.
Measured: Week 52
Number of Patients with Adverse Events
Number of Patients with Adverse Events
Measured: Week 12
Total Number (and Type) of Adverse Events
Total Number (and Type) of Adverse Events
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Aug 2023
- Primary completion10 Jan 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199091
- Sponsor's protocol ID
- 19-8759-BO
- Acronym
- CRANIO4ME
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2019
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniosacral Therapy Versus Progressive Muscle Relaxation as Self-help Strategies for Patients With Chronic Non-specific Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04199091
- Acronym / sponsor ID
- CRANIO4ME / 19-8759-BO
- Keywords
- Craniosacral Therapy, Low Back Pain, Chronic, Randomized Controlled Trial, Self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Craniosacral self-help techniques (CST) | Experimental | Procedure: Craniosacral Therapy (CST) self-help techniquesThe 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) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Specific back pain due to:
- Severe congenital or acute degenerative diseases
- Severe inflammatory musculoskeletal or rheumatic diseases
- Neurological diseases
- Status after actue trauma/whiplash
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniosacral Therapy (CST) self-help techniquesManual self-help techniques based on Craniosacral Therapy (group setting). | Procedure or surgery | Craniosacral self-help techniques (CST) |
| Progressive Muscle Relaxation (PMR)Progressive muscle relaxation according to Jacobsen (group setting). | Procedure or surgery | Progressive muscle relaxation (PMR) |
Primary outcome
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.
19 secondary outcomes
Functional Impairment
Time frame: Week 26
Functional Impairment
Time frame: Week 52
Pain Intensity
Time frame: Week 12
Pain Intensity
Time frame: Week 26
Pain Intensity
Time frame: Week 52
Health-related Quality of Life
Time frame: Week 12
Health-related Quality of Life
Time frame: Week 26
Health-related Quality of Life
Time frame: Week 52
Severity of Depressive Symptoms
Time frame: Week 12
Severity of Depressive Symptoms
Time frame: Week 26
Severity of Depressive Symptoms
Time frame: Week 52
Severity of Anxious Symptoms
Time frame: Week 12
Severity of Anxious Symptoms
Time frame: Week 26
Severity of Anxious Symptoms
Time frame: Week 52
Global Improvement
Time frame: Week 12
Global Improvement
Time frame: Week 26
Global Improvement
Time frame: Week 52
Number of Patients with Adverse Events
Time frame: Week 12
Total Number (and Type) of Adverse Events
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, Prof. MD study director
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniosacral Therapy (CST) self-help techniques and Progressive Muscle Relaxation (PMR) in people with Low Back Pain, Mechanical and Complementary Therapies, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Impairment (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.