Cervical Radicular PainPhase 2NCT00395798
Effect of Cervical Collar in Cervical Radicular Pain.
A Phase 2 study testing Soft or stiff cervical collar(device), neck school(behavior) in people with Cervical Radicular Pain, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Radicular Pain
- What is being tested?
- Soft or stiff cervical collar(device), neck school(behavior)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Aug 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cervical radicular pain caused by herniated disc og spondolytic spurs
- written consent from patient
Who cannot join
- previous necksurgery
- whiplash or other necktrauma
- serious diseases somatic or psychiatric
- patients not able to speak and read Norwegian well
- insufficient correlation between clinical and radiological findings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study
Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with "neck school information" with "neck school information" alone.
- Conditions
- Cervical Radicular Pain
- Being tested
- Soft or stiff cervical collar(device), neck school(behavior)
- Keywords
- cervical intervertebral disc displacement, cervical spondylosis, radiculopathy, neck collar, brace, physiotherapy, treatment, rehabilitation
- Medical subject headings
- Spondylosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft or stiff cervical collar(device), neck school(behavior)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
painscore on visual analog scale 0-100mm after 6weeks treatment
Secondary outcomes (3)
painscore visual analog scale 0-100mm after 3weeks,3months,1year
Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year
Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startJan 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Radicular PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Investigators
- Vibeke Graver, PhD, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395798
- Sponsor's protocol ID
- EVisi
- Status last verified
- May 2006
- First submitted
- 2 Nov 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conservative Treatment With Cervical Collar in Patients With Cervical Radiculopathy and Radicular Pain. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00395798
- Acronym / sponsor ID
- EVisi
- Conditions
- Cervical Radicular Pain
- Keywords
- cervical intervertebral disc displacement, cervical spondylosis, radiculopathy, neck collar, brace, physiotherapy, treatment, rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Jan 2004
- Study completion
- Aug 2007
- First posted
- 3 Nov 2006 (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.
Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with "neck school information" with "neck school information" alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cervical radicular pain caused by herniated disc og spondolytic spurs
- written consent from patient
Key exclusion criteria (5 listed)
- previous necksurgery
- whiplash or other necktrauma
- serious diseases somatic or psychiatric
- patients not able to speak and read Norwegian well
- insufficient correlation between clinical and radiological findings
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 |
|---|---|---|
| Soft or stiff cervical collar(device), neck school(behavior) | Device | – |
Primary outcome
painscore on visual analog scale 0-100mm after 6weeks treatment
3 secondary outcomes
painscore visual analog scale 0-100mm after 3weeks,3months,1year
Functional status on Neck pain and disability index after 3weeks,6weeks,3months,1 year
Quality of life score, Cantrils Ladder Scale 3 weeks,6weeks,3 months,1 year
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 6 Jul 2011.
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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.
Vibeke Graver, PhD study director
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soft or stiff cervical collar(device), neck school(behavior) in people with Cervical Radicular Pain, run by Ullevaal University Hospital at 1 site in Norway.
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 2 inclusion and 5 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
painscore on visual analog scale 0-100mm after 6weeks treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2011.