Cervical RadiculopathyPhase 2NCT00308594
Oral Dexamethasone for the Treatment of Cervical Radiculopathy
A Phase 2 study testing Dexamethasone in people with Cervical Radiculopathy, run by University of Manitoba.
Trial summary
The purpose of this study is to determine whether dexamethasone is effective in the treatment of pain and disability resulting from a compressed spinal nerve in the neck (cervical radiculopathy). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Dexamethasone
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Nov 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 - 60
- arm and neck pain consistent with cervical radiculopathy
- Neck Disability Index score of at least 15 (moderate)
- symptom onset between 2 weeks and 6 months prior to enrollment
Who cannot join
- Actively immunosuppressed state
- clinical red flags consistent with possible infection or malignancy
- acute febrile illness or infection requiring antibiotics
- upper motor neuron signs consistent with myelopathy
- previous orthopedic neck surgery in the area of that nerve root
- known hepatic dysfunction
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- schizophrenia
- pregnancy/nursing mothers
- previous chronic corticosteroid use
- diabetes mellitus on treatment
- rapidly improving course
- osteoporosis
- hypersensitivity to product components
- systemic fungal infection
- recent administration of live vaccine
- active tuberculosis
- glaucoma
- peptic ulcer disease
About this study
Official title: Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial
The purpose of this study is to determine whether dexamethasone is effective in the treatment of pain and disability resulting from a compressed spinal nerve in the neck (cervical radiculopathy).
Read the detailed description
Cervical radiculopathy is causes both short and long term pain and diability. The current proven treatments include pain killers or surgery if there if patients experience progressive weakness or signs or spinal cord compression. Observations in both animal models and humans indicate that there is an inflammatory component to it. Corticosteroids (such as dexamethasone)are potent anti-inflammatories which may benefit people suffering from this condition. There is some evidence to support neck injections of drug directly onto the nerve root. This mmethod of drug delivery has been implicated with some serious complications such as paralysis and stroke. Delivering these medications in a pill form may provide a similar benefit without some of the serious complications.
- Conditions
- Cervical Radiculopathy
- Being tested
- Dexamethasone
- Keywords
- cervical radiculopathy, dexamethasone, corticosteroid, oral
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Secondary outcomes (3)
Visual Numeric Scale for arm & neck pain
Days missed from work
Cervical Radiculopathy Neurologic Impairment Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Study terminated due to withdrawl of participating co-investigators.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Dave R Hooper, MD BSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308594
- Sponsor's protocol ID
- B2006:027
- Status last verified
- Apr 2011
- First submitted
- 28 Mar 2006
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00308594
- Acronym / sponsor ID
- B2006:027
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical radiculopathy, dexamethasone, corticosteroid, oral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to withdrawl of participating co-investigators.
- Enrolment
- 100 participants
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 29 Mar 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.
The purpose of this study is to determine whether dexamethasone is effective in the treatment of pain and disability resulting from a compressed spinal nerve in the neck (cervical radiculopathy).
Detailed description
Cervical radiculopathy is causes both short and long term pain and diability. The current proven treatments include pain killers or surgery if there if patients experience progressive weakness or signs or spinal cord compression. Observations in both animal models and humans indicate that there is an inflammatory component to it. Corticosteroids (such as dexamethasone)are potent anti-inflammatories which may benefit people suffering from this condition. There is some evidence to support neck injections of drug directly onto the nerve root. This mmethod of drug delivery has been implicated with some serious complications such as paralysis and stroke. Delivering these medications in a pill form may provide a similar benefit without some of the serious complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18 - 60
- arm and neck pain consistent with cervical radiculopathy
- Neck Disability Index score of at least 15 (moderate)
- symptom onset between 2 weeks and 6 months prior to enrollment
Key exclusion criteria (18 listed)
- Actively immunosuppressed state
- clinical red flags consistent with possible infection or malignancy
- acute febrile illness or infection requiring antibiotics
- upper motor neuron signs consistent with myelopathy
- previous orthopedic neck surgery in the area of that nerve root
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 |
|---|---|---|
| Dexamethasone | Drug | – |
Primary outcome
Neck Disability Index
3 secondary outcomes
Visual Numeric Scale for arm & neck pain
Days missed from work
Cervical Radiculopathy Neurologic Impairment Scale
Results and safety
The study was stopped early (reason given: Study terminated due to withdrawl of participating co-investigators.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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.
Dave R Hooper, MD BSc principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Cervical Radiculopathy, run by University of Manitoba.
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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Study terminated due to withdrawl of participating co-investigators.). Results are not available in the source record.
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?
Neck Disability Index. 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 28 Apr 2011.