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The purpose of this randomized controlled trial is to determinate the efficacy and safety of Craniosacral Therapy in the treatment of chronic unspecific neck pain.
Craniosacral Therapy (CST) is a variation of osteopathic manipulation with an integrative approach. By soft manual palpation of the craniosacral and fascia system sensory, motor, cognitive, and emotional processes can be influenced. In the prevention and treatment of chronic pain syndromes Craniosacral Therapy is demonstrated to be effective in clinical practice and quite a few scientific trials. But yet there are no randomized controlled studies concerning to chronic neck pain. So the aim of this study is to investigate whether a total of 8 CST units of 45 minutes will be effective in patients suffering from chronic nonspecific neck pain in contrast to sham therapy of the same extent. The prospective study design includes measurement points at baseline, post treatment, and 3 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Craniosacral Therapy (CST) | Experimental | Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes. |
|
| Sham Craniosacral Therapy (SHAM) | Sham Comparator | Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Craniosacral Therapy | Procedure | Standardized therapy protocol (according to Upledger): Still point technique, diaphragm release, compression-decompression and lift techniques of the cranial bones, facial balancing in the region of shoulder and pelvis and somato-emotional unwinding |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity on a 100mm visual analogue scale (VAS) | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity in motion | Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS) | week 8 |
| Pressure pain threshold | Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof. MD | Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte | Essen | North Rhine-Westphalia | 45276 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25453528 | Background | Haller H, Ostermann T, Lauche R, Cramer H, Dobos G. Credibility of a comparative sham control intervention for Craniosacral Therapy in patients with chronic neck pain. Complement Ther Med. 2014 Dec;22(6):1053-9. doi: 10.1016/j.ctim.2014.09.007. Epub 2014 Oct 6. | |
| 26340656 | Result | Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290. |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham Craniosacral Therapy | Procedure | Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention |
|
| week 8 |
| Disability | Measured by the Neck Disability Indx (NDI) | week 8 |
| Quality of life | Measured by the Short-Form Health Survey (SF-12) | week 8 |
| Well being | Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16) | week 8 |
| Anxiety and depression | Measured by the Hospital Anxiety and Depression Scale (HADS) | week 8 |
| Stress perception | Measured by the Perceived Stress Questionnaire (PSQ-20) | week 8 |
| Pain acceptance | Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA) | week 8 |
| Body awareness | Measured by the Scale of Body Connection (SBC) | week 8 |
| Global Impression | Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I) | week 8 |
| Safety | All adverse events are recorded | week 8 |