Comparison of Gabapentin and Pregabalin for Radicular Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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Although some studies show improvement of pain and associated effects of pain with off-label use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published evidence so far. We propose to complete a year-long prospective, observational study as a pilot to recruit 400 patients within the year and follow their pain level, function, and QOL measures for 16 weeks to determine whether it is feasible to continue studying this group in the future. We expect that pain, function, and quality of life will be improved in the group of patients who are given neuropathic agents as an adjunct to other conservative treatments compared to the expected 65% of patients with similar symptoms who are treated conservatively without neuropathic agents. We do not expect a statistically significant difference between the two neuropathic agents.

Since these drugs are currently used off-label, there is limited empirical evidence regarding which agent is more efficacious compared to the other, and since their use in treating radicular pain is based mostly on anecdotal evidence so far, prescription of one or the other of these agents has been based on likely compliance (medication needed twice a day, three times a day) or whether or not the patients' insurance will pay for one or the other. This study will be a first step to better assist practitioners in counselling their patients on use of these medications in radiculopathy, examining rates of discontinuation due to side effects and what effects these medications have on perceived pain, function and quality of life.

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Detailed Description

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Conditions

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Radicular; Neuropathic, Lumbar, Lumbosacral Radicular; Neuropathic, Cervical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group G - receiving gabapentin

Receiving gabapentin as standard of care. No intervention

No interventions assigned to this group

Group P - receiving pregabalin

Receiving pregabalin as standard of care No intervention

No interventions assigned to this group

Group Z - no neuropathic agent

Receiving only conservative treatment No drug treatment No intervention

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Cervical or lumbar radicular complaints with clinical diagnosis of radiculopathy or sciatica
* Aged 18 years and older
* Able to provide informed consent either with or without a legally authorized representative
* Patients with VAS\> or = 4 (Visual Analog Pain score)

Exclusion Criteria

* Under the age of 18
* Previously completed epidural injections within 3 weeks of the study
* Undergone cervical or lumbar surgery
* History of renal disease, metastatic disease to the spine, vertebral fractures
* Individuals with pending litigation, workers compensation claims or disability claims
* Unable to provide informed consent and no legally authorized representative is available

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No