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NOT YET RECRUITING
NCT07691359
PHASE4

Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

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.

Official title: Preventive Effect of 5% Lidocaine Plaster on the Development of Neuropathic Pain Following Osteoporotic Vertebral Fracture: A Proof-of-concept, Controlled, Randomized Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-07-01

Completion Date

2028-10-01

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Lidocaine 5% medicated plaster

A 5% lidocaine plaster applied once daily for 12 hours followed by 12 hours without the plaster for 2 months.

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France