ArticleTrials2025
Gabapentin versus placebo for the treatment of acute lumbosacral radicular pain caused by disc herniation: study protocol of the GRADE randomized controlled double-blind superiority trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04865042 (Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study
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0 citing papers in PubMed.
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8 authors.
Funding
Abstract
backgroundAcute lumbosacral radiculopathy from disc herniation is common and particularly painful. The challenge is to provide sufficient relief to patients until the natural regression of the herniated disc allows them to heal, primarily using conservative medical treatment combining physical measures, antinociceptive analgesics, and systemic anti-inflammatory drugs. Nerve root impingement is likely to cause acute neuropathic pain, which is not currently managed by standard conservative medical treatment. We hypothesised that a short course of gabapentin could improve pain management in acute lumbosacral radiculopathy from disc herniation.
methodsThe GRADE (Gabapentin versus placebo for the treatment of acute lumbosacral RAdicular pain caused by Disc hErniation) study is a prospective, randomized, multicenter, double-blind, superiority phase III trial comparing a 3-day regimen of gabapentin to placebo with a 1:1 ratio. Patients with acute lumbosacral radiculopathy from disc herniation with symptoms of less than 3 months are included in 6 centres in France. The primary outcome is the change in the radicular pain Visual Analogue Scale between Day 1 and Day 4. Intention-to-treat analysis will be applied primarily. DISCUSSION: Ethics approval was obtained from the committee for the protection of persons (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 1: 1-21-023 ID 11548). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the pain management in acute lomboradicular pain. TRIAL REGISTRATION NUMBER: EudraCT: 2020-002849-42 Clinicaltrials NCT04865042. 19 April 2021.
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