[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646540":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5% Lidocaine Plaster","EXPERIMENTAL","Participants receive a 5% lidocaine plaster applied daily (12 hours on\u002F12 hours off) for 2 months in addition to standard care.",[13],"Drug: Lidocaine 5% medicated plaster",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","Participants receive standard care without a 5% lidocaine plaster.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Lidocaine 5% medicated plaster","A 5% lidocaine plaster applied once daily for 12 hours followed by 12 hours without the plaster for 2 months.",[9],[26],{"name":27,"affiliation":5,"role":28},"Marie-Eva PICKERING","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Lise Laclautre","CONTACT","0473754963","promo_interne_drci@chu-clermontferrand.fr",[36],{"facility":37,"status":18,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":18},"CHU Clermont-Ferrand","Clermont-Ferrand","63000","France","FR",{"type":43,"coordinates":44},"Point",[45,46],3.08682,45.77969,{"lat":46,"lon":45},{"type":49,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100646540","phase-4-osteoporotic-fracture-and-lidocaine-plaster-5-for-neuropathic-pain-prevention-100646540",false,"NCT07691359","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","FLYNN","Inclusion Criteria:\n\n* Male or female participant aged 50 years or older.\n* Diagnosis of osteoporosis established by the treating rheumatologist.\n* Osteoporotic vertebral fracture diagnosed within the previous month.\n* Pain intensity of ≥3 on a numerical rating scale at the fracture site.\n* Able and willing to provide written informed consent.\n* Affiliated with a French health insurance system.\n\nExclusion Criteria:\n\n* Medical or surgical condition considered by the investigator to be incompatible with study participation.\n* Known hypersensitivity to lidocaine, any excipient of the study treatment, or other amide-type local anesthetics.\n* Current treatment with Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics.\n* Inflamed or damaged skin at the intended application site (e.g., active herpes zoster lesions, dermatitis, or wounds).\n* Pregnant or breastfeeding women.\n* Women of childbearing potential not using an effective contraceptive method.\n* Positive urine pregnancy test for women whose menopausal status cannot be confirmed.\n* Participation in another clinical research study.\n* Individuals under legal protection or deprived of liberty.\n* Refusal to participate.","ALL","50 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","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.",[68,69],"Osteoporotic Vertebral Fracture","Neuropathic Pain",[71,72,73,74,75,76],"Lidocaine 5% Plaster","Lidocaine Patch","Osteoporosis","Pain Prevention","PainDETECT","DN4","NOT_YET_RECRUITING","2026-07-02",{"date":80,"type":81},"2026-07-08","ACTUAL",{"date":83,"type":62},"2026-07-01",{"date":85,"type":62},"2028-10-01",{"name":5,"class":6},1]