Back to resultsEffect of Cervical Collar in Cervical Radicular Pain.
Primary Purpose
Cervical Radicular Pain
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Soft or stiff cervical collar(device), neck school(behavior)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radicular Pain focused on measuring cervical intervertebral disc displacement, cervical spondylosis, radiculopathy, neck collar, brace, physiotherapy, treatment, rehabilitation
Eligibility 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
Sites / Locations
- Ullevaal University Hospital
Outcomes
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
Full Information
NCT ID
NCT00395798
First Posted
November 2, 2006
Last Updated
July 3, 2011
Sponsor
Ullevaal University Hospital
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
1. Study Identification
Unique Protocol Identification Number
NCT00395798
Brief Title
Effect of Cervical Collar in Cervical Radicular Pain.
Official Title
Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radicular Pain
Keywords
cervical intervertebral disc displacement, cervical spondylosis, radiculopathy, neck collar, brace, physiotherapy, treatment, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Soft or stiff cervical collar(device), neck school(behavior)
Primary Outcome Measure Information:
Title
painscore on visual analog scale 0-100mm after 6weeks treatment
Secondary Outcome Measure Information:
Title
painscore visual analog scale 0-100mm after 3weeks,3months,1year
Title
Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year
Title
Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke Graver, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
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Effect of Cervical Collar in Cervical Radicular Pain.
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