NCT00308594

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

March 28, 2006

Last Update Submit

April 27, 2011

Conditions

Cervical Radiculopathy

Keywords

cervical radiculopathydexamethasonecorticosteroidoral

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

Secondary Outcomes (3)

  • Visual Numeric Scale for arm & neck pain

  • Days missed from work

  • Cervical Radiculopathy Neurologic Impairment Scale

Interventions

DexamethasoneDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiculopathy

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Dave R Hooper, MD BSc

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 28, 2011

Record last verified: 2011-04