Effects of Craniosacral Therapy on Chronic Neck Pain (CranioS)

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Craniosacral Therapy; Procedure: Sham Craniosacral Therapy

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Haller H, Ostermann T, Lauche R, Cramer H, Dobos G. Credibility of a comparative sham control intervention for Craniosacral Therapy in patients with chronic neck pain. Complement Ther Med. 2014 Dec;22(6):1053-9. doi: 10.1016/j.ctim.2014.09.007. Epub 2014 Oct 6.
• Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (ESTIMATE): February 3, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Randomized Controlled Trial; Neck Pain; Sensory Thresholds; Complementary Therapies; Craniosacral Manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 11-4850