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NCT04199091: CRANIO4ME
Craniosacral Therapy as a Self-help Strategy for Patients With Chronic Non-specific Back Pain
NA trial testing Craniosacral Therapy (CST) self-help techniques in Low Back Pain, Mechanical in 76 participants. Completed in 29 September 2025.
10 January 2025
Quick facts
| Lead sponsor | Universität Duisburg-Essen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 1 August 2023 |
| Primary completion | 10 January 2025 |
| Estimated completion | 29 September 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Craniosacral Therapy (CST) self-help techniques
- Progressive Muscle Relaxation (PMR)
Conditions studied
- Low Back Pain, Mechanical — all drugs for Low Back Pain, Mechanical →
- Complementary Therapies — all drugs for Complementary Therapies →
- Progressive Muscle Relaxation — all drugs for Progressive Muscle Relaxation →
Sponsor
Universität Duisburg-Essen — full company profile →
Who can join
18 and older, any sex, with Low Back Pain, Mechanical or Complementary Therapies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04199091
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Low Back Pain, Mechanical
Currently open trials in the same condition.
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- NCT06718348 — Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain · NA · recruiting
- NCT07150702 — Effects of Close Follow-up on Patients With Low Back Pain · NA · recruiting
- NCT07031947 — The Effect of Core Stabilization Exercises Applied With Virtual Reality-Based Telerehabilitation in the Treatment of Chr · NA · active not recruiting
Other Universität Duisburg-Essen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04199091 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universität Duisburg-Essen
- Last refreshed: 24 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04199091.
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