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Oral Dexamethasone for the Treatment of Cervical Radiculopathy

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ClinicalTrials.gov Identifier: NCT00308594
Recruitment Status : Terminated (Study terminated due to withdrawl of participating co-investigators.)
First Posted : March 29, 2006
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Drug: Dexamethasone Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial
Study Start Date : November 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Neck Disability Index

Secondary Outcome Measures :
  1. Visual Numeric Scale for arm & neck pain
  2. Days missed from work
  3. Cervical Radiculopathy Neurologic Impairment Scale

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308594


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

ClinicalTrials.gov Identifier: NCT00308594     History of Changes
Other Study ID Numbers: B2006:027
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011

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
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action