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Effects of Craniosacral Therapy on Chronic Neck Pain (CranioS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526447
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : February 21, 2019
Information provided by (Responsible Party):
Heidemarie Haller, 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.

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Craniosacral Therapy Procedure: Sham Craniosacral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Pain intensity [ Time Frame: week 8 ]
    Pain intensity on a 100mm visual analogue scale (VAS)

Secondary Outcome Measures :
  1. Pain intensity in motion [ Time Frame: week 8 ]
    Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)

  2. Pressure pain threshold [ Time Frame: week 8 ]
    Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum

  3. Disability [ Time Frame: week 8 ]
    Measured by the Neck Disability Indx (NDI)

  4. Quality of life [ Time Frame: week 8 ]
    Measured by the Short-Form Health Survey (SF-12)

  5. Well being [ Time Frame: week 8 ]
    Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)

  6. Anxiety and depression [ Time Frame: week 8 ]
    Measured by the Hospital Anxiety and Depression Scale (HADS)

  7. Stress perception [ Time Frame: week 8 ]
    Measured by the Perceived Stress Questionnaire (PSQ-20)

  8. Pain acceptance [ Time Frame: week 8 ]
    Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)

  9. Body awareness [ Time Frame: week 8 ]
    Measured by the Scale of Body Connection (SBC)

  10. Global Impression [ Time Frame: week 8 ]
    Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)

  11. Safety [ Time Frame: week 8 ]
    All adverse events are recorded

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526447

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Kliniken Essen-Mitte
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
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Study Director: Gustav Dobos, Prof. MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany
Publications of Results:
Other Publications:
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Responsible Party: Heidemarie Haller, Postdoctoral Research Fellow, Universität Duisburg-Essen Identifier: NCT01526447    
Other Study ID Numbers: 11-4850
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Keywords provided by Heidemarie Haller, Universität Duisburg-Essen:
Neck Pain
Craniosacral Manipulation
Complementary Therapies
Randomized Controlled Trial
Sensory Thresholds
Quality of Life
Additional relevant MeSH terms:
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Neck Pain
Neurologic Manifestations