[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporotic-vertebral-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporotic-vertebral-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Osteoporotic Vertebral Fracture","Neuropathic Pain",[30,31,32,33,34,35],"Lidocaine 5% Plaster","Lidocaine Patch","Osteoporosis","Pain Prevention","PainDETECT","DN4","NOT_YET_RECRUITING","2026-07-02",{"date":39,"type":40},"2026-07-08","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2028-10-01",{"name":46,"class":47},"University Hospital, Clermont-Ferrand","OTHER"]