An interventional study of Craniosacral Therapy and Sham Craniosacral Therapy in Neck Pain, sponsored by Universität Duisburg-Essen. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Neck Pain; 254 are open to participants now.
This study's enrollment of 54 is close to the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Universität Duisburg-Essen is the lead sponsor of 82 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.
Procedure: Craniosacral Therapy
Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.
Procedure: Sham Craniosacral Therapy
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
Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention
Pain intensity
Pain intensity on a 100mm visual analogue scale (VAS)
Time frame: week 8
Pain intensity in motion
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)
Time frame: week 8
Pressure pain threshold
Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
Time frame: week 8
Disability
Measured by the Neck Disability Indx (NDI)
Time frame: week 8
Quality of life
Measured by the Short-Form Health Survey (SF-12)
Time frame: week 8
Well being
Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
Time frame: week 8
Anxiety and depression
Measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: week 8
Stress perception
Measured by the Perceived Stress Questionnaire (PSQ-20)
Time frame: week 8
Pain acceptance
Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
Time frame: week 8
Body awareness
Measured by the Scale of Body Connection (SBC)
Time frame: week 8
Global Impression
Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
Time frame: week 8
Safety
All adverse events are recorded
Time frame: week 8
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Universität Duisburg-Essen