Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN

Starting soon · Phase 4

Conditions studied: Osteoporotic Vertebral Fracture, Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT07691359

Run by

University Hospital, Clermont-Ferrand

People needed

30

Starts

2026-07-01

Expected to finish

2028-10-01

Last updated by the study team

2026-07-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CHU Clermont-Ferrand — Clermont-Ferrand, France

Full record on ClinicalTrials.gov

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