Effects of Craniosacral Therapy on Chronic Neck Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Procedure: Craniosacral Therapy
* Procedure: Sham Craniosacral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic unspecific neck pain for at least 3 months Mean neck pain of moderate intensity (>/=45mm on VAS) Therapy-naive subjects Exclusion Criteria: Specific neck pain due to severe deformity of the spine, prolapse, rheumatic or neurological disorder, trauma, operation or cancer other severe somatic or psychiatric comorbidity pregnancy regular intake of opiates, corticosteroids (>10mg prednisolon), muscle relaxants or antidepressants recent invasive or manipulative treatment of the spine participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Craniosacral Therapy (CST)<br>Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes. | Procedure: Craniosacral Therapy<br>* 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<br>|
| Sham Comparator: Sham Craniosacral Therapy (SHAM)<br>Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes. | Procedure: Sham Craniosacral Therapy<br>* Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity on a 100mm visual analogue scale (VAS) | week 8 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck Pain, Craniosacral Manipulation, Complementary Therapies, Randomized Controlled Trial, Sensory Thresholds, Quality of Life