drugset / Trial / NCT07691359
Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2027-10-01
- Completion
- 2028-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 5 % | Topical |