NCT02064790

Comparison of Gabapentin and Pregabalin for Radicular Pain

Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-02-17
• Last updated: 2016-03-09

Locations

1 site across 1 country: United States