drugset / Trial / NCT07691359

Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN

NCT07691359

Phase 4 Not yet recruiting 30 enrolled University Hospital, Clermont-Ferrand
RandomizedParallel-groupOpen-labelPrevention

Summary

Osteoporotic vertebral fractures may lead to chronic pain with a neuropathic component, which is often underdiagnosed and undertreated in older adults. This proof-of-concept randomized controlled trial aims to evaluate whether early application of a 5% lidocaine plaster can prevent the development of neuropathic pain following an osteoporotic vertebral fracture. Participants will be randomized in a 2:1 ratio to receive either a daily 5% lidocaine plaster plus standard care or standard care alone for 2 months. The primary outcome is the proportion of participants who develop neuropathic pain at 2 months, assessed using the PainDETECT questionnaire.

Timeline

Start
2026-07-01
Primary completion
2027-10-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 5 % Topical