Westeinde Brachialgia Study

Not Applicable

Completed

• Conditions: Radiculopathy, Cervical
• Interventions: Other: cervical collar; Other: physiotherapy

• Registration Number: NCT00129714
• Lead Sponsor: Medical Center Haaglanden

Brief Summary

The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with acute cervical radiculopathy.

Detailed Description

Cervical radiculopathy caused by spondylosis or disc protrusion is a common disorder with a usually benign natural course. Often, physiotherapy (exercise programs) and/or cervical collar are prescribed. However, there are no reliable data on the effects of these conservative therapies.

In this study, patients with acute cervical radiculopathy, defined by clinical criteria, are randomized for cervical collar, physiotherapy or a wait-and-see policy.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-08-10
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-12
• Primary Completion: 2007-04
• Study Completion: 2007-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following: provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm; or muscle weakness in one or more adjacent myotomes.

Exclusion Criteria

• Arm pain existing longer than one month
• Clinical signs of spinal cord compression
• Previously treated with physiotherapy or a cervical collar

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
collar	cervical collar	-
physiotherapy	physiotherapy	-

Primary Outcome Measures

Name	Time	Method
pain and disability at 3 and 6 weeks and at 6 months

Secondary Outcome Measures

Name	Time	Method
time back to work
persistent signs and symptoms
surgery

Trial Locations

Locations (3)

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

Medical Center Haaglanden; 🇳🇱 Den Haag, Netherlands