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Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial

Cited 7 time in Web of Science Cited 5 time in Scopus
Authors
Kim, Ho-Joong; Kim, Jin Hyok; Park, Ye Soo; Suk, Kyung-Soo; Lee, Jae Hyup; Park, Moon Soo; Moon, Seong-Hwan
Issue Date
2016-06
Publisher
ELSEVIER SCIENCE INC
Citation
The Spine Journal, Vol.16 No.6, pp. 756-763
Keywords
Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial의약학Lumbar spinal stenosisLimaprostPregabalinCombined treatmentNon-inferiority trialrandomized controlled trialOswestry disability indexVisual analog scaleEuropean Quality of Life 5 dimensionEQ-5DInitial claudication distance
Abstract
BACKGROUND CONTEXT: Although the simultaneous management of neuronal ischemia-related pain and compression-demyelination-related neuropathic pain is considered optimal in treating lumbar spinal stenosis (LSS), the effect of combination therapy with pregabalin and limaprost has not been elucidated.PURPOSE: This study aimed to compare the effects of limaprost and pregabalin individually and in combination for the treatment of LSS.STUDY DESIGN: This is a prospective, double-blind, double-dummy, randomized controlled trial.PATIENT SAMPLE: The sample consists of patients with LSS.OUTCOME MEASURES: The baseline-adjusted Oswestry Disability Index (ODI) score, visual analog scale (VAS) scores for leg pain, the European Quality of Life-5 dimensions (EQ-5D), and initial claudication distance (ICD).METHODS: The present study (ClinicalTrials.gov, number NCT01888536) was a prospective, double-blind, double-dummy, randomized controlled trial designed to determine the efficacy of limaprost in alleviating leg pain, improving disability, and increasing walking distance in persons with degenerative LSS in three different treatment groups: limaprost alone, pregabalin alone, and combined limaprost and pregabalin through 1:1:1 allocation. The primary outcome was the baseline-adjusted ODI score at 8 weeks after treatment. The non-inferior margin of the ODI was set at delta=10 points.RESULTS: The baseline-adjusted ODI score (primary outcome) at 8 weeks after treatment in the limaprost group was not inferior to those in the pregabalin and limaprost+pregabalin groups. The overall changes of the baseline-adjusted ODI scores, VAS scores for leg pain, the EQ-5D, and ICD during the follow-up assessments over an 8-week period (secondary end point) were not different among the three groups. The baseline-adjusted ODI scores and VAS scores for leg pain decreased significantly over time after treatment in all three groups. The baseline-adjusted EQ-5D score and ICD also increased significantly over time after treatment in all three groups.CONCLUSIONS: The efficacy of limaprost for lumbar spinal stenosis was not inferior compared with that of pregabalin or the combination of limaprost and pregabalin in terms of disability. Therefore, combined treatment with limaprost and pregabalin does not provide additional relief in symptoms in patients with LSS compared with monotherapy with limaprost or pregabalin. (C) 2016 Published by Elsevier Inc.
ISSN
1529-9430
Language
English
URI
https://hdl.handle.net/10371/116985
DOI
https://doi.org/10.1016/j.spinee.2016.02.049
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College of Medicine/School of Medicine (의과대학/대학원)Orthopedic Surgery (정형외과학전공)Journal Papers (저널논문_정형외과학전공)
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