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Oral Dexamethasone for the Treatment of Cervical Radiculopathy

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00308594
Enrollment
100
Registered
2006-03-29
Start date
2006-11-30
Completion date
2007-11-30
Last updated
2011-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Radiculopathy

Keywords

cervical radiculopathy, dexamethasone, corticosteroid, oral

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.

Interventions

DRUGDexamethasone

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Neck Disability Index

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026