Lidocaine 5% medicated plaster: A 5% lidocaine plaster applied once daily for 12 hours followed by 12 hours without the plaster for 2 months.
Study 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Development of neuropathic pain at 2 months — Baseline - Day 0 and Visit 2 - Day 60 Percentage of participants who develop neuropathic pain 2 months after enrollment, assessed using the PainDETECT questionnaire. This self-administered questionnaire evaluates pain quality, temporal pattern, and radiation to estimate the likelihood of neuropathic pain. The total score allows classification of pain as unlikely, possible, or likely neuropathic. Neuropathic pain is defined as a PainDETECT score ≥19.
Trial sites (1)
Facility
City
Region
Status
CHU Clermont-Ferrand
Clermont-Ferrand
France
More University Hospital, Clermont-Ferrand trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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