Clinical Trial: Westeinde Brachialgia Study

This study is currently recruiting patients.
Verified by Medical Center Haaglanden August 2005

Sponsored by: Medical Center Haaglanden
Information provided by: Medical Center Haaglanden
ClinicalTrials.gov Identifier: NCT00129714

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
 Procedure: cervical collar, physiotherapy

MedlinePlus related topics:  Peripheral Nerve Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title: A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy

Further Study Details: 
Primary Outcomes: pain and disability at 3, 6 weeks and 6 months
Secondary Outcomes: back to work; persistent signs and symptoms; surgery
Expected Total Enrollment:  240

Study start: August 2003;  Expected completion: December 2007
Last follow-up: August 2007;  Data entry closure: August 2007

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

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129714

Barbara Kuijper      0031703302000    b.kuijper@mchaaglanden.nl

Netherlands
      Medical Center Haaglanden, Den Haag,  2501CK,  Netherlands; Recruiting
B Kuijper
J TJ Tans
B Kuijper,  Principal Investigator

      Meander Medical Center, Amersfoort,  Netherlands; Recruiting
W GH Oerlemans

      Groene Hart Ziekenhuis, Gouda,  Netherlands; Recruiting
G AM Verheul
J E Dalman

Study chairs or principal investigators

Jos TJ Tans, MD PhD,  Study Chair,  Medical Center Haaglanden   

More Information

Study ID Numbers:  542
Last Updated:  August 11, 2005
Record first received:  August 10, 2005
ClinicalTrials.gov Identifier:  NCT00129714
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
ClinicalTrials.gov processed this record on 2005-08-23

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