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Effect of Cervical Collar in Cervical Radicular Pain.

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Ullevaal University Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00395798
  Purpose

Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with "neck school information" with "neck school information" alone.


Condition Intervention Phase
Cervical Radicular Pain
Device: Soft or stiff cervical collar(device), neck school(behavior)
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • painscore on visual analog scale 0-100mm after 6weeks treatment

Secondary Outcome Measures:
  • painscore visual analog scale 0-100mm after 3weeks,3months,1year
  • Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year
  • Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year

Estimated Enrollment:   120
Study Start Date:   January 2004
Estimated Study Completion Date:   August 2007

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • cervical radicular pain caused by herniated disc og spondolytic spurs
  • written consent from patient

Exclusion Criteria:

  • previous necksurgery
  • whiplash or other necktrauma
  • serious diseases somatic or psychiatric
  • patients not able to speak and read Norwegian well
  • insufficient correlation between clinical and radiological findings
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395798

Locations
Norway
Ullevaal University Hospital    
      Oslo, Norway, 0407

Sponsors and Collaborators
Ullevaal University Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy

Investigators
Study Director:     Vibeke Graver, PhD     Ullevaal University Hospital    
  More Information


Study ID Numbers:   EVisi
First Received:   November 2, 2006
Last Updated:   November 2, 2006
ClinicalTrials.gov Identifier:   NCT00395798
Health Authority:   Norway:Center for Clinical Research UUH

Keywords provided by Ullevaal University Hospital:
cervical intervertebral disc displacement  
cervical spondylosis  
radiculopathy  
neck collar  
brace
physiotherapy
treatment
rehabilitation

Study placed in the following topic categories:
Radiculopathy
Pain
Intervertebral Disk Displacement

ClinicalTrials.gov processed this record on September 23, 2008




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