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Oral Dexamethasone for the Treatment of Cervical Radiculopathy

This study has been terminated.
(Study terminated due to withdrawl of participating co-investigators.)
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00308594
First received: March 28, 2006
Last updated: April 27, 2011
Last verified: April 2011

March 28, 2006
April 27, 2011
November 2006
November 2007   (final data collection date for primary outcome measure)
Neck Disability Index
Same as current
Complete list of historical versions of study NCT00308594 on ClinicalTrials.gov Archive Site
  • Visual Numeric Scale for arm & neck pain
  • Days missed from work
  • Cervical Radiculopathy Neurologic Impairment Scale
Same as current
Not Provided
Not Provided
 
Oral Dexamethasone for the Treatment of Cervical Radiculopathy
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cervical Radiculopathy
Drug: Dexamethasone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00308594
B2006:027
No
Not Provided
University of Manitoba
Not Provided
Principal Investigator: Dave R Hooper, MD BSc University of Manitoba
University of Manitoba
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP