Effect of Cervical Collar in Cervical Radicular Pain.

Cervical Radicular Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395798
• Other study ID #: EVisi
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2006
• Last updated: July 3, 2011
• Start date: January 2004
• Est. completion date: August 2007

Study information

• Verified date: May 2006
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:Center for Clinical Research UUH
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Radicular Pain

Intervention

Device:
• Soft or stiff cervical collar(device), neck school(behavior)

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	painscore on visual analog scale 0-100mm after 6weeks treatment
Secondary	painscore visual analog scale 0-100mm after 3weeks,3months,1year
Secondary	Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year
Secondary	Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year