Effect of Cervical Collar in Cervical Radicular Pain.
This study has been completed.
Sponsor:
Ullevaal University Hospital
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00395798
First received: November 2, 2006
Last updated: July 3, 2011
Last verified: May 2006
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Further study details as provided by Oslo 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
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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: NCT00395798
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00395798 History of Changes |
| Other Study ID Numbers: | EVisi |
| Study First Received: | November 2, 2006 |
| Last Updated: | July 3, 2011 |
| Health Authority: | Norway:Center for Clinical Research UUH |
Keywords provided by Oslo University Hospital:
|
cervical intervertebral disc displacement cervical spondylosis radiculopathy neck collar |
brace physiotherapy treatment rehabilitation |
ClinicalTrials.gov processed this record on March 03, 2015