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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
History of Changes
  Purpose

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).


Condition Intervention Phase
Cervical Radiculopathy
 Drug: Dexamethasone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

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

Estimated Enrollment: 100
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308594

Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Dave R Hooper, MD BSc University of Manitoba
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00308594     History of Changes
Other Study ID Numbers: B2006:027
Study First Received: March 28, 2006
Last Updated: April 27, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
cervical radiculopathy
dexamethasone
corticosteroid
oral

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013