Objective: The purpose of this open-label study was to assess the effectiveness and tolerability of levetiracetam (LEV) in the treatment of patients with lower lumbar radiculopathy diagnosed by clinical presentation, physical examination, and electrodiagnostics.
Design: Open-label, forced titration, prospective cohort intent-to-treat analysis.
Setting: Major teaching hospital.
Patients: Participants were recruited from the university pain clinic and through referrals from the community. Subjects were eligible to participate if they (1) were older than 18 years, (2) had leg pain greater than back pain, (3) had been symptomatic for 6 months and <5 years, (3) had a baseline visual analog scale of at least 6 on the 0-10 scale, (4) had undergone lumbar spine magnetic resonance imaging within the last 12 months that showed no surgically correctable etiology for their radicular symptoms, and (5) had undergone electrodiagnostics that was positive for lumbar radiculopathy (L4, L5, or S1 nerve roots). Twenty-six patients were enrolled, and 24 (92.3%) completed the study.
Interventions: Patients initially received LEV 500 mg twice a day for 2 weeks. Dosages were then increased to 750 mg twice day for 2 weeks, and then to 1500 mg twice a day for the remainder of the study. Patients were observed for 8 weeks after reaching the maximum dose.
Main outcome measurements: Treatment effectiveness was assessed with the use of biweekly brief pain inventory and patient global assessment scales. Frequency and severity of adverse events were recorded.
Results: The mean biweekly worst and average pain scores decreased from 7.17 and 6.27 at baseline to 4.2 and 3.9, respectively, at week 12 (P < or = .001). Improvements were reported in general activity, ability to walk, mood, and relationship with people. Side effects consisted of sedation/drowsiness (46%), gastrointestinal upset (23%), headache (19%), blurred vision (15%), weakness/fatigue (11%), and dyscoordination (11%).
Conclusions: This study showed that LEV might be a well-tolerated and effective treatment for lumbar radiculopathy. A large randomized placebo-controlled trial is recommended and comparative studies with alternative agents should be sought.