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
  Purpose

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 Intervention
Neck Pain
Procedure: Craniosacral Therapy
Procedure: Sham Craniosacral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Pain intensity on a 100mm visual analogue scale (VAS)


Secondary Outcome Measures:
  • 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


Enrollment: 54
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526447

Locations
Germany
Kliniken Essen-Mitte
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Study Chair: Gustav J. Dobos, Prof. Chair of Complementary and Integrative Medicine, University Duisburg-Essen, Germany
  More Information

No publications provided

Responsible Party: Heidemarie Haller, MSc, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01526447     History of Changes
Other Study ID Numbers: 11-4850
Study First Received: February 1, 2012
Last Updated: May 13, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universität Duisburg-Essen:
Neck Pain
Craniosacral Manipulation
Complementary Therapies
Randomized Controlled Trial
Sensory Thresholds
Quality of Life

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014