Lidocaine plaster to prevent nerve pain after an osteoporotic spine fracture
Tests a lidocaine plaster to prevent nerve pain after osteoporotic spine fracture.
Plain-language title generated from the registry record
Registry title: Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
Key facts
- Where
- Clermont-Ferrand, FranceSee the site
- Phase
- Phase 4
Where in France
- CHU Clermont-FerrandClermont-Ferrand, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Clermont-Ferrand
- Trial code
- NCT07691359EU 2025-524889-25-00
- Record updated
- 8 July 2026
- Original description
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.Read full original descriptionShow less
Preventive Effect of 5% Lidocaine Plaster on the Development of Neuropathic Pain Following Osteoporotic Vertebral Fracture: A Proof-of-concept, Controlled, Randomized Trial
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: 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: Current treatment with Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics; 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; 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.