Oral Dexamethasone for the Treatment of Cervical Radiculopathy

Cervical Radiculopathy Clinical Trial

Official title:

Oral Dexamethasone for the Treatment of Cervical Radiculopathy: A Double Blinded, Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00308594
• Other study ID #: B2006:027
• Status: Terminated
• Phase: Phase 2
• First received: March 28, 2006
• Last updated: April 27, 2011
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Drug:
• Dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index
Secondary	Visual Numeric Scale for arm & neck pain
Secondary	Days missed from work
Secondary	Cervical Radiculopathy Neurologic Impairment Scale