Comparison of Gabapentin and Pregabalin for Radicular Pain
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|ClinicalTrials.gov Identifier: NCT02064790|
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : March 9, 2016
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.
|Condition or disease|
|Radicular; Neuropathic, Lumbar, Lumbosacral Radicular; Neuropathic, Cervical|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Group G - receiving gabapentin
Receiving gabapentin as standard of care. No intervention
Group P - receiving pregabalin
Receiving pregabalin as standard of care No intervention
Group Z - no neuropathic agent
Receiving only conservative treatment No drug treatment No intervention
- Pain reduction with Visual Analogue Scale [ Time Frame: 8 weeks ]
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.
- To compare the efficacy of each of the two neuropathic agents to the other in treatment of cervical or lumbar radiculopathy [ Time Frame: 8 weeks ]
Outcome measures below will be used.
Oswestry Low Back Pain Disability Questionnaire (ODO) Neck Disability Index (NDI) Usage/Reduction of non-neuropathic pain meds at each interval Side effects of medications
- To determine the rate of compliance and reported side effects related to the neuropathic agent used. [ Time Frame: 8 weeks ]
There will be a less than 15% discontinuation rate secondary to side effects in either of the two neuropathic agents.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064790
|United States, Georgia|
|Emory Orthopaedics and Spine Center|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Diana Sodiq, D.O.||Emory University|