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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
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
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
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)
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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