Westeinde Brachialgia Study

Radiculopathy, Cervical Clinical Trial

— WEB  

Official title:

A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129714
• Other study ID #: 542
• Status: Completed
• Phase: N/A
• First received: August 10, 2005
• Last updated: April 23, 2012
• Start date: August 2003
• Est. completion date: July 2007

Study information

• Verified date: April 2012
• Source: Medical Center Haaglanden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Radiculopathy
• Radiculopathy, Cervical

Intervention

Other:
• cervical collar

• physiotherapy

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort
Netherlands	Medical Center Haaglanden	Den Haag
Netherlands	Groene Hart Ziekenhuis	Gouda

Sponsors (1)

Lead Sponsor	Collaborator
Medical Center Haaglanden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain and disability at 3 and 6 weeks and at 6 months
Secondary	time back to work
Secondary	persistent signs and symptoms
Secondary	surgery