Radiculopathy, CervicalWEBNCT00129714
Westeinde Brachialgia Study
A study testing cervical collar and physiotherapy in people with Radiculopathy, Cervical, run by Medical Center Haaglanden at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiculopathy, Cervical
- What is being tested?
- cervical collar and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesNetherlands
- Study dates
- Aug 2003to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Arm pain existing longer than one month
- Clinical signs of spinal cord compression
- Previously treated with physiotherapy or a cervical collar
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Meander Medical Center
Amersfoort
Groene Hart Ziekenhuis
Gouda
Medical Center Haaglanden
The Hague, 2501CK
About this study
Official title: A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy
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.
Read the 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.
- Conditions
- Radiculopathy, Cervical
- Being tested
- cervical collar, physiotherapy
- Keywords
- cervical radiculopathy conservative treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical collarOther
physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| wait and see | No intervention | Not described |
| collar | Experimental | Not described Receives: Other: cervical collar |
| physiotherapy | Experimental | Not described Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain and disability at 3 and 6 weeks and at 6 months
Secondary outcomes (3)
time back to work
persistent signs and symptoms
surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startAug 2003
- Primary completionApr 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Medical Center Haaglanden
- Sponsor type
- University, hospital or other
- Investigators
- Jos TJ Tans, MD PhD, Study chair, Medical Center Haaglanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129714
- Sponsor's protocol ID
- 542
- Acronym
- WEB
- Status last verified
- Apr 2012
- First submitted
- 10 Aug 2005
- Last updated
- 24 Apr 2012
- Results posted
- No
Publications
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.
PubMed 19812130Kuijper 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.
PubMed 19087147
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT00129714
- Acronym / sponsor ID
- WEB / 542
- Conditions
- Radiculopathy, Cervical
- Keywords
- cervical radiculopathy conservative treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Medical Center HaaglandenUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| wait and see | No intervention | – |
| collar | Experimental | Other: cervical collar |
| physiotherapy | Experimental | Other: physiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Arm pain existing longer than one month
- Clinical signs of spinal cord compression
- Previously treated with physiotherapy or a cervical collar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical collar | Other | collar |
| physiotherapy | Other | physiotherapy |
Primary outcome
pain and disability at 3 and 6 weeks and at 6 months
3 secondary outcomes
time back to work
persistent signs and symptoms
surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- Derived from this study: PubMed 19812130Kuijper 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.
- Derived from this study: PubMed 19087147Kuijper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jos TJ Tans, MD PhD study chair
Medical Center Haaglanden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical collar and physiotherapy in people with Radiculopathy, Cervical, run by Medical Center Haaglanden at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain and disability at 3 and 6 weeks and at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129714, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.