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Effects of Craniosacral Therapy on Chronic Neck Pain (CranioS)

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ClinicalTrials.gov Identifier: NCT01526447
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen

Tracking Information
First Submitted Date  ICMJE February 1, 2012
First Posted Date  ICMJE February 3, 2012
Last Update Posted Date February 21, 2019
Study Start Date  ICMJE February 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
Pain intensity [ Time Frame: week 8 ]
Pain intensity on a 100mm visual analogue scale (VAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • 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)
  • Pressure pain threshold [ Time Frame: week 8 ]
    Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
  • Disability [ Time Frame: week 8 ]
    Measured by the Neck Disability Indx (NDI)
  • Quality of life [ Time Frame: week 8 ]
    Measured by the Short-Form Health Survey (SF-12)
  • Well being [ Time Frame: week 8 ]
    Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
  • Anxiety and depression [ Time Frame: week 8 ]
    Measured by the Hospital Anxiety and Depression Scale (HADS)
  • Stress perception [ Time Frame: week 8 ]
    Measured by the Perceived Stress Questionnaire (PSQ-20)
  • Pain acceptance [ Time Frame: week 8 ]
    Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
  • Body awareness [ Time Frame: week 8 ]
    Measured by the Scale of Body Connection (SBC)
  • Global Impression [ Time Frame: week 8 ]
    Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
  • Safety [ Time Frame: week 8 ]
    All adverse events are recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Craniosacral Therapy on Chronic Neck Pain
Official Title  ICMJE Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • 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
  • Procedure: Sham Craniosacral Therapy
    Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention
Study Arms  ICMJE
  • Experimental: Craniosacral Therapy (CST)
    Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.
    Intervention: Procedure: Craniosacral Therapy
  • Sham Comparator: Sham Craniosacral Therapy (SHAM)
    Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.
    Intervention: Procedure: Sham Craniosacral Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2012)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01526447
Other Study ID Numbers  ICMJE 11-4850
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidemarie Haller, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gustav Dobos, Prof. MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany
PRS Account Universität Duisburg-Essen
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP