Effect of Cervical Collar in Cervical Radicular Pain.

This study has been completed.

Sponsor:

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

History of Changes

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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


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

Additional relevant MeSH terms:


Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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