Comparison of Gabapentin and Pregabalin for Radicular Pain

NCT02064790 | Completed

• 1 other identifier: IRB00069871
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gabapentin; Pregabalin; Lyrica; Neurontin; lumbar; cervical

Outcome Measures

Primary Outcomes (1)

• Pain reduction with Visual Analogue Scale

  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.

  8 weeks

Secondary Outcomes (1)

• To compare the efficacy of each of the two neuropathic agents to the other in treatment of cervical or lumbar radiculopathy

  8 weeks

Other Outcomes (1)

• To determine the rate of compliance and reported side effects related to the neuropathic agent used.

  8 weeks

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants of both genders and all ethnicities will be invited to participate in this study as they present to Emory Orthopaedics and Spine Clinic and are diagnosed with and treated for cervical or lumbar radicular pain.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

Study Officials

• Diana Sodiq, D.O.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedics

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (1)