NCT07691359Not yet recruitingPhase 4
Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
Preventive Effect of 5% Lidocaine Plaster on the Development of Neuropathic Pain Following Osteoporotic Vertebral Fracture: A Proof-of-concept, Controlled, Randomized Trial
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Osteoporosis
- NCT number
- NCT07691359
- EU CT number
- 2025-524889-25-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Jul 2026 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.