Oral Dexamethasone for the Treatment of Cervical Radiculopathy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 28, 2006

Last Updated Date

March 21, 2007

Start Date ^†

November 2006

Current Primary Outcome Measures ^†

Neck Disability Index

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00308594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^†

Cervical Radiculopathy

Intervention ^†

Drug: Dexamethasone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

100

Completion Date

November 2008

Primary Completion Date

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00308594

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Manitoba

Collaborators ^††

Investigators ^†

Principal Investigator:

Dave R Hooper, MD BSc

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

March 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.