Effects of Craniosacral Therapy on Chronic Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Procedure: Sham Craniosacral Therapy; Procedure: Craniosacral Therapy

• Registration Number: NCT01526447
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

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

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Craniosacral Therapy (SHAM)	Sham Craniosacral Therapy	Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.
Craniosacral Therapy (CST)	Craniosacral Therapy	Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.

Primary Outcome Measures

Name	Time	Method
Pain intensity	week 8	Pain intensity on a 100mm visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Pain intensity in motion	week 8	Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)
Disability	week 8	Measured by the Neck Disability Indx (NDI)
Quality of life	week 8	Measured by the Short-Form Health Survey (SF-12)
Global Impression	week 8	Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
Safety	week 8	All adverse events are recorded
Pressure pain threshold	week 8	Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
Anxiety and depression	week 8	Measured by the Hospital Anxiety and Depression Scale (HADS)
Pain acceptance	week 8	Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
Stress perception	week 8	Measured by the Perceived Stress Questionnaire (PSQ-20)
Well being	week 8	Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
Body awareness	week 8	Measured by the Scale of Body Connection (SBC)

Trial Locations

Locations (1)

Kliniken Essen-Mitte; 🇩🇪 Essen, NRW, Germany