Effect of Cervical Collar in Cervical Radicular Pain.

This study is ongoing, but not recruiting participants.

First Received: November 2, 2006 No Changes Posted

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

No publications provided

Study ID Numbers:	EVisi
Study First Received:	November 2, 2006
Last Updated:	November 2, 2006
ClinicalTrials.gov Identifier:	NCT00395798 History of Changes
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 May 07, 2009