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Effects of Craniosacral Therapy on Chronic Neck Pain (CranioS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01526447
First received: February 1, 2012
Last updated: May 13, 2013
Last verified: May 2013

February 1, 2012
May 13, 2013
February 2012
December 2012   (final data collection date for primary outcome measure)
Pain intensity [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Pain intensity on a 100mm visual analogue scale (VAS)
Same as current
Complete list of historical versions of study NCT01526447 on ClinicalTrials.gov Archive Site
  • Pain intensity in motion [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
  • Disability [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Neck Disability Indx (NDI)
  • Quality of life [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Short-Form Health Survey (SF-12)
  • Well being [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
  • Anxiety and depression [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Hospital Anxiety and Depression Scale (HADS)
  • Stress perception [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Perceived Stress Questionnaire (PSQ-20)
  • Pain acceptance [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
  • Body awareness [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Scale of Body Connection (SBC)
  • Global Impression [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
  • Safety [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    All adverse events are recorded
Same as current
Not Provided
Not Provided
 
Effects of Craniosacral Therapy on Chronic Neck Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neck Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01526447
11-4850
Yes
Heidemarie Haller, Universität Duisburg-Essen
Universität Duisburg-Essen
Not Provided
Study Chair: Gustav J. Dobos, Prof. Chair of Complementary and Integrative Medicine, University Duisburg-Essen, Germany
Universität Duisburg-Essen
May 2013

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