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TerminatedNCT00308594Updated Apr 28, 2011

Oral Dexamethasone for the Treatment of Cervical Radiculopathy

A Phase 2 interventional study of Dexamethasone in Cervical Radiculopathy, sponsored by University of Manitoba. Terminated. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-04-28.

Sponsored by University of Manitoba · Phase 2, Interventional, and Treatment

Why this study was terminated
Study terminated due to withdrawl of participating co-investigators.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cervical Radiculopathy

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Keywords

  • cervical radiculopathy
  • dexamethasone
  • corticosteroid
  • oral
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
100 participants

Interventions

  • DrugDexamethasone
06

What researchers measure

Primary outcomes

  1. Neck Disability Index

Secondary outcomes

  1. Visual Numeric Scale for arm & neck pain

  2. Days missed from work

  3. Cervical Radiculopathy Neurologic Impairment Scale

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00308594
Lead sponsor
University of Manitoba
First posted
Mar 29, 2006
Start date
Nov 2006
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Apr 28, 2011

Study contacts

Dave R Hooper, MD BSc
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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