Westeinde Brachialgia Study

NCT ID: NCT00129714

Last Updated: 2012-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Radiculopathy, Cervical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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wait and see

Group Type NO_INTERVENTION

No interventions assigned to this group

collar

Group Type EXPERIMENTAL

cervical collar

Intervention Type OTHER

physiotherapy

Group Type EXPERIMENTAL

physiotherapy

Intervention Type OTHER

Interventions

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cervical collar

Intervention Type OTHER

physiotherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Center Haaglanden

OTHER

Sponsor Role lead

Principal Investigators

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Jos TJ Tans, MD PhD

Role: STUDY_CHAIR

Medical Center Haaglanden

Locations

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Meander Medical Center

Amersfoort, , Netherlands

Site Status

Groene Hart Ziekenhuis

Gouda, , Netherlands

Site Status

Medical Center Haaglanden

The Hague, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 19812130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19087147 (View on PubMed)

Other Identifiers

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542

Identifier Type: -

Identifier Source: org_study_id

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