CranioS: Effects of Craniosacral Therapy on Chronic Neck Pain

Sponsor

Universität Duisburg-Essen (Other)

Overall Status

Completed

CT.gov ID

NCT01526447

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Procedure: Craniosacral Therapy Procedure: Sham Craniosacral Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Craniosacral Therapy (CST)

Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.

Procedure: 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

Sham Comparator: Sham Craniosacral Therapy (SHAM)

Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.

Procedure: Sham Craniosacral Therapy

Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention

Outcome Measures

Primary Outcome Measures

Pain intensity [week 8]
Pain intensity on a 100mm visual analogue scale (VAS)

Secondary Outcome Measures

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)
Pressure pain threshold [week 8]
Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
Disability [week 8]
Measured by the Neck Disability Indx (NDI)
Quality of life [week 8]
Measured by the Short-Form Health Survey (SF-12)
Well being [week 8]
Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
Anxiety and depression [week 8]
Measured by the Hospital Anxiety and Depression Scale (HADS)
Stress perception [week 8]
Measured by the Perceived Stress Questionnaire (PSQ-20)
Pain acceptance [week 8]
Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
Body awareness [week 8]
Measured by the Scale of Body Connection (SBC)
Global Impression [week 8]
Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
Safety [week 8]
All adverse events are recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kliniken Essen-Mitte	Essen	NRW	Germany	45276

Sponsors and Collaborators

Universität Duisburg-Essen

Investigators

Study Director: Gustav Dobos, Prof. MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany