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Effect of Cervical Collar in Cervical Radicular Pain.

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ClinicalTrials.gov Identifier: NCT00395798
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : July 6, 2011
Sponsor:
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by:
Oslo University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Cervical Radicular Pain Device: Soft or stiff cervical collar(device), neck school(behavior) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study
Study Start Date : January 2004
Study Completion Date : August 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. painscore on visual analog scale 0-100mm after 6weeks treatment

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00395798     History of Changes
Other Study ID Numbers: EVisi
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: May 2006

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

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases