Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN

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.

Inclusion Criteria: * Male or female participant aged 50 years or older. * Diagnosis of osteoporosis established by the treating rheumatologist. * Osteoporotic vertebral fracture diagnosed within the previous month. * Pain intensity of ≥3 on a numerical rating scale at the fracture site. * Able and willing to provide written informed consent. * Affiliated with a French health insurance system. Exclusion Criteria: * Medical or surgical condition considered by the investigator to be incompatible with study participation. * Known hypersensitivity to lidocaine, any excipient of the study treatment, or other amide-type local anesthetics. * Current treatment with Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics. * Inflamed or damaged skin at the intended application site (e.g., active herpes zoster lesions, dermatitis, or wounds). * Pregnant or breastfeeding women. * Women of childbearing potential not using an effective contraceptive method. * Positive urine pregnancy test for women whose menopausal status cannot be confirmed. * Participation in another clinical research study. * Individuals under legal protection or deprived of liberty. * Refusal to participate.