Westeinde Brachialgia Study | NCT00129714

Studies
Westeinde Brachialgia Study

NCT00129714

Sponsor

Medical Center Haaglanden

Status

Completed

Last Update Posted

Apr 24, 2012Estimated

Enrollment

240

Phase

Not Applicable

Conditions

Radiculopathy, Cervical

Interventions

cervical collar
physiotherapy

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Apr 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Aug 10, 2005

First Submission Date that Met QC Criteria

Aug 11, 2005

First Posted Date

Aug 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2012

Last Update Posted Date

Apr 24, 2012Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
wait and see	No Intervention
collar	Experimental	Other: cervical collar
physiotherapy	Experimental	Other: physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cervical collar	Other		collar
physiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain and disability at 3 and 6 weeks and at 6 months

Secondary Outcomes

Measure	Description	Time Frame
time back to work
persistent signs and symptoms
surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jos TJ Tans, MD PhD	Medical Center Haaglanden	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meander Medical Center		Amersfoort			Netherlands
Groene Hart Ziekenhuis

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19812130	Derived	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.
19087147	Derived	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.

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Term
D013812	Therapeutics
D012046	Rehabilitation