Comparative study on the efficacy of pregabalin versus limaprost in patients with lumbar spinal stenosis: A prospective, randomized controlled trial

Background Patients with Lumbar Spinal Stenosis (LSS) typically complain of back pain and leg pain. These symptoms reduce the quality of life and also cause sleep disturbances. This study compares pregabalin and limaprost's efficacy in LSS for pain, disability, quality of life, and sleep, aiming to offer insights for medication selection. Methods This study was designed as a prospective, randomized, single-center, single-blinded, clinical superiority trial targeting patients with LSS. For 6 weeks, 111 patients per group were administered medication following a standard regimen, after which patient-reported outcomes were measured. The primary outcome was the Visual Analogue Scale (VAS) for back and leg pain, and the secondary outcomes included the Oswestry Disability Index (ODI), European Quality of Life 5 Dimensions (EQ-5D), and sleep quality. Results After 6 weeks of medication, there were significant improvements over time in the primary outcome, VAS for back pain and leg pain, in both groups, but no significant difference between the two groups. Similarly, for the secondary outcomes, ODI and EQ-5D, both groups showed significant improvements, yet there was no significant difference between them. In the subgroup analysis targeting poor sleepers (Pittsburgh sleep quality index, PSQI > 5), both groups also exhibited significant improvements in sleep quality, but again, there was no significant difference between the groups. Conclusions Efficacy of pregabalin, limaprost in back and leg pain, ODI, EQ-5D, and sleep quality, but there was no significant difference between the two groups. Thus, it is advisable to prescribe based on individual drug responses and potential complications.