search
Back to results

Westeinde Brachialgia Study (WEB)

Primary Purpose

Radiculopathy, Cervical

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
cervical collar
physiotherapy
Sponsored by
Medical Center Haaglanden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy, Cervical focused on measuring cervical radiculopathy conservative treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meander Medical Center
  • Medical Center Haaglanden
  • Groene Hart Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

wait and see

collar

physiotherapy

Arm Description

Outcomes

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

Full Information

First Posted
August 10, 2005
Last Updated
April 23, 2012
Sponsor
Medical Center Haaglanden
search

1. Study Identification

Unique Protocol Identification Number
NCT00129714
Brief Title
Westeinde Brachialgia Study
Acronym
WEB
Official Title
A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Center Haaglanden

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Cervical
Keywords
cervical radiculopathy conservative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Arm Title
wait and see
Arm Type
No Intervention
Arm Title
collar
Arm Type
Experimental
Arm Title
physiotherapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
cervical collar
Intervention Type
Other
Intervention Name(s)
physiotherapy
Primary Outcome Measure Information:
Title
pain and disability at 3 and 6 weeks and at 6 months
Secondary Outcome Measure Information:
Title
time back to work
Title
persistent signs and symptoms
Title
surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jos TJ Tans, MD PhD
Organizational Affiliation
Medical Center Haaglanden
Official's Role
Study Chair
Facility Information:
Facility Name
Meander Medical Center
City
Amersfoort
Country
Netherlands
Facility Name
Medical Center Haaglanden
City
Den Haag
ZIP/Postal Code
2501CK
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19812130
Citation
Kuijper B, Tans JT, Beelen A, Nollet F, de Visser M. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial. BMJ. 2009 Oct 7;339:b3883. doi: 10.1136/bmj.b3883.
Results Reference
derived
PubMed Identifier
19087147
Citation
Kuijper B, Tans JT, Schimsheimer RJ, van der Kallen BF, Beelen A, Nollet F, de Visser M. Degenerative cervical radiculopathy: diagnosis and conservative treatment. A review. Eur J Neurol. 2009 Jan;16(1):15-20. doi: 10.1111/j.1468-1331.2008.02365.x.
Results Reference
derived

Learn more about this trial

Westeinde Brachialgia Study

We'll reach out to this number within 24 hrs