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Clinical Trials/NCT01526447
NCT01526447
Completed
Not Applicable

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

Universität Duisburg-Essen1 site in 1 country54 target enrollmentFebruary 2012
ConditionsNeck Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
Universität Duisburg-Essen
Enrollment
54
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
April 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heidemarie Haller

Postdoctoral Research Fellow

Universität Duisburg-Essen

Eligibility 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

Outcomes

Primary Outcomes

Pain intensity

Time Frame: week 8

Pain intensity on a 100mm visual analogue scale (VAS)

Secondary Outcomes

  • Pain intensity in motion(week 8)
  • Pain acceptance(week 8)
  • Disability(week 8)
  • Quality of life(week 8)
  • Global Impression(week 8)
  • Safety(week 8)
  • Pressure pain threshold(week 8)
  • Anxiety and depression(week 8)
  • Stress perception(week 8)
  • Well being(week 8)
  • Body awareness(week 8)

Study Sites (1)

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