Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Clermont-Ferrand
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Lidocaine 5% medicated plaster
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov