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Oral Dexamethasone for the Treatment of Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
University of Manitoba
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring cervical radiculopathy, dexamethasone, corticosteroid, oral

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Neck Disability Index

    Secondary Outcome Measures

    Visual Numeric Scale for arm & neck pain
    Days missed from work
    Cervical Radiculopathy Neurologic Impairment Scale

    Full Information

    First Posted
    March 28, 2006
    Last Updated
    April 27, 2011
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00308594
    Brief Title
    Oral Dexamethasone for the Treatment of Cervical Radiculopathy
    Official Title
    Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study terminated due to withdrawl of participating co-investigators.
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy
    Keywords
    cervical radiculopathy, dexamethasone, corticosteroid, oral

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Primary Outcome Measure Information:
    Title
    Neck Disability Index
    Secondary Outcome Measure Information:
    Title
    Visual Numeric Scale for arm & neck pain
    Title
    Days missed from work
    Title
    Cervical Radiculopathy Neurologic Impairment Scale

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dave R Hooper, MD BSc
    Organizational Affiliation
    University of Manitoba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Dexamethasone for the Treatment of Cervical Radiculopathy

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