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NCT02064790 · ClinicalTrials.gov registry record

Comparison of Gabapentin and Pregabalin for Radicular Pain

A clinical trial, sponsored by Emory University.

Completed
Registry status
6
Enrollment target

NCT02064790: Completed study, sponsored by Emory University.

NCT02064790 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02064790 has completed, sponsored by Emory University.

COMPLETED
Registry status
6 participants
Enrollment target

Study Summary

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.

Primary Outcome

Specific Aim 1: To determine the efficacy of addition of gabapentin or pregabalin to conservative management for pain reduction in patients with cervical or lumbar radiculopathy. Hypothesis 1: There is a significant improvement of pain level with addition of one of the neuropathic agents for patients with radiculopathy compared to patients who are treated without them.

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2014-04
Est. Completion 2015-12
Emory University

1,208 total trials

What the finished NCT02064790 record still lists

NCT02064790 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02064790 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02064790 about?

NCT02064790 is a clinical study titled "Comparison of Gabapentin and Pregabalin for Radicular Pain". 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 patie...

What is the current status of trial NCT02064790?

This trial is currently completed. The enrollment target is 6 participants. The study started on 2014-04. Estimated completion is 2015-12.

Who is sponsoring clinical trial NCT02064790?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02064790, the US trial registry maintained by the National Library of Medicine. NCT02064790 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.