Comparison of Gabapentin and Pregabalin for Radicular Pain

Emory University

Status

Completed

Conditions

Radicular; Neuropathic, Cervical

Radicular; Neuropathic, Lumbar, Lumbosacral

Study type

Observational

Funder types

Other

Identifiers

NCT02064790

IRB00069871

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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