Oral Dexamethasone for the Treatment of Cervical Radiculopathy

NCT ID: NCT00308594

Last Updated: 2011-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-11-30

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.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Dexamethasone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Principal Investigators

Dave R Hooper, MD BSc

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Other Identifiers

B2006:027

Identifier Type: -

Identifier Source: org_study_id