Effect of Cervical Collar in Cervical Radicular Pain.

July 3, 2011 updated by: Ullevaal University Hospital

Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study

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.

Study Overview

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0407
        • Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
painscore on visual analog scale 0-100mm after 6weeks treatment

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Vibeke Graver, PhD, Ullevaal University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

August 1, 2007

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 2, 2006

First Posted (ESTIMATE)

November 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

May 1, 2006

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Radicular Pain

Clinical Trials on Soft or stiff cervical collar(device), neck school(behavior)

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