NCT00129714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

3.7 years

First QC Date

August 10, 2005

Last Update Submit

April 23, 2012

Conditions

Keywords

cervical radiculopathy conservative treatment

Outcome Measures

Primary Outcomes (1)

  • pain and disability at 3 and 6 weeks and at 6 months

Secondary Outcomes (3)

  • time back to work

  • persistent signs and symptoms

  • surgery

Study Arms (3)

wait and see

NO INTERVENTION

collar

EXPERIMENTAL
Other: cervical collar

physiotherapy

EXPERIMENTAL
Other: physiotherapy

Interventions

collar
physiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Arm pain existing longer than one month
  • Clinical signs of spinal cord compression
  • Previously treated with physiotherapy or a cervical collar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Meander Medical Center

Amersfoort, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Medical Center Haaglanden

The Hague, 2501CK, Netherlands

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Radiculopathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Jos TJ Tans, MD PhD

    Medical Center Haaglanden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2005

First Posted

August 12, 2005

Study Start

August 1, 2003

Primary Completion

April 1, 2007

Study Completion

July 1, 2007

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations