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Efficacy of Gabapentin and Pregabalin for the Treatment
of Neurogenic Claudication in Lumbar Spinal Stenosis:
A Double-blinded Randomized Placebo-controlled Trial
Chatupon Chotigavanichaya, Korawish Mekariya, Borriwat Santipas, Sirichai Wilartratsami,
Ekkapoj Korwutthikulrangsri, Monchai Ruangchainikom, Panya Luksanapruksa*
Department of Orthopaedic Surgery, Faculty of Medicine, Siriraj Hospital, Mahidol University
*Corresponding Author E-mail: cutecarg@yahoo.com
Background: Methods: Abstract
Gabapentin (GBA) and pregabalin (PGB) are frequently prescribed for neurogenic
intermittent claudication (NIC) associated with lumbar spinal stenosis (LSS). However,
current evidence supporting their efficacy—either in comparison to placebo or in head-to-
head trials—is limited. We aimed to evaluate the efficacy of GBA and PGB compared to
placebo in alleviating NIC symptoms and improving functional outcomes in LSS patients.
This double-blinded, randomized, placebo-controlled trial included MRI-confirmed LSS
patients with predominant NIC symptoms for ≥3 months. Participants were randomized
(1:1:1) to receive GBA (1800 mg/day), PGB (300 mg/day), or placebo in addition to standard
conservative management, including physical therapy and naproxen. GBA and PGB
were both titrated to the effective dose over 14 days. The primary outcome was NIC pain
measured by the Visual Analog Scale (VAS). Secondary outcomes included the Swiss Spinal
Stenosis Score (SSS), self-paced shuttle walk test (SPSWT; time to NIC symptoms and
walking distance), EQ-5D-5L, and adverse effects. All outcomes were assessed monthly
over 4 months.
Results: Ninety patients (mean age 63.14 ± 9.70 years, mean symptoms duration 19.38 ± 4.11
months) were included. All groups demonstrated significant improvements in VAS, SSS,
SPSWT, and EQ-5D-5L at 4 months. At 1 and 2 months, PGB showed greater EQ-5D-5L
improvement compared to GBA (mean differences: 0.07 [p = 0.045] and 0.08 [p = 0.001],
respectively). No significant differences in other outcomes were observed between groups
at any time point. Adverse effects, including dizziness and sedation, were more common in
the GBA and PGB groups compared to placebo (p < 0.001).
Conclusions: GBA and PGB did not demonstrate superior efficacy over placebo in reducing NIC and
improving functional outcomes in LSS. Moreover, their use was associated with a higher
incidence of adverse effects. These findings suggest limited utility for gabapentinoids as
adjunctive treatments for LSS.
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