Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN (NCT07691359) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
France30 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.