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Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
Sponsor: University Hospital, Clermont-Ferrand
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
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