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Westeinde Brachialgia Study (WEB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00129714
First Posted: August 12, 2005
Last Update Posted: April 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Center Haaglanden
  Purpose
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.

Condition Intervention
Radiculopathy, Cervical Other: cervical collar Other: physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy

Further study details as provided by Medical Center Haaglanden:

Primary Outcome Measures:
  • pain and disability at 3 and 6 weeks and at 6 months

Secondary Outcome Measures:
  • time back to work
  • persistent signs and symptoms
  • surgery

Estimated Enrollment: 240
Study Start Date: August 2003
Study Completion Date: July 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: wait and see
Experimental: collar Other: cervical collar
Experimental: physiotherapy Other: physiotherapy

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129714


Locations
Netherlands
Meander Medical Center
Amersfoort, Netherlands
Medical Center Haaglanden
Den Haag, Netherlands, 2501CK
Groene Hart Ziekenhuis
Gouda, Netherlands
Sponsors and Collaborators
Medical Center Haaglanden
Investigators
Study Chair: Jos TJ Tans, MD PhD Medical Center Haaglanden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00129714     History of Changes
Other Study ID Numbers: 542
First Submitted: August 10, 2005
First Posted: August 12, 2005
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Medical Center Haaglanden:
cervical radiculopathy conservative treatment

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases