[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626154":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":49,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum Toxin Type A","EXPERIMENTAL","Single ultrasound-guided perineural injection of botulinum toxin type A (100 units diluted in 2.0 mL saline) administered around the confirmed neuroma using a standardized grid injection technique.",[13],"Drug: Botulinium toxin type A injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Local Anesthetic (Active Control)","ACTIVE_COMPARATOR","Single ultrasound-guided perineural injection of local anesthetic (ropivacaine 0.2%, 2.0 mL or bupivacaine 0.25%, 2.0 mL) administered around the confirmed neuroma using the identical technique and volume.",[19],"Drug: Local Anesthesia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Botulinium toxin type A injection","A single ultrasound-guided perineural injection of botulinum toxin type A (100 units diluted in 2.0 mL sterile normal saline) administered circumferentially around the imaging-confirmed neuroma using a standardized grid injection technique. The procedure is performed under sterile conditions with real-time ultrasound visualization to ensure accurate perineural placement. No additional corticosteroids or anesthetics are co-administered.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Local Anesthesia","A single ultrasound-guided perineural injection of local anesthetic (ropivacaine 0.2%, 2.0 mL or bupivacaine 0.25%, 2.0 mL) administered circumferentially around the imaging-confirmed neuroma using the identical injection technique and volume as the experimental arm. The procedure is performed under sterile conditions with real-time ultrasound guidance. No corticosteroids are administered.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dmytro Dmytriiev, PhD.Professor","CONTACT","+380674309449","d.dmytriiev@superhumans.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Superhumans War Trauma Center","Lviv","Ukraine","UA",{"type":44,"coordinates":45},"Point",[46,47],24.02324,49.83826,{"lat":47,"lon":46},{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626154","silencing-neuroma-pain-botulinum-toxin-versus-local-anesthetic-injection-100626154",false,"NCT07431944","Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection","SILENCE-NEUROMA Trial: Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection in a Randomized Controlled Trial","SILENCE-NEUROM","Inclusion Criteria:\n\n* Age ≥18 years\n* History of limb trauma and\u002For limb amputation at least 3 months prior to enrollment\n* Clinical diagnosis of neuroma-related pain with focal tenderness and positive - - Tinel sign\n* Imaging confirmation of neuroma by ultrasound or MRI\n* Average pain intensity ≥4 on a 0-10 Numerical Rating Scale (NRS) during the week prior to screening\n* Stable analgesic regimen for at least 14 days prior to enrollment\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Chronic pain condition unrelated to neuroma that predominates clinical symptoms\n* infection at or near the planned injection site\n* Known neuromuscular junction disorders (e.g., myasthenia gravis)\n* Pregnancy or breastfeeding\n* Botulinum toxin treatment within the previous 4-6 months\n* Planned surgical neuroma revision during the study period\n* allergy or hypersensitivity to botulinum toxin or local anesthetics","ALL","18 Years","50 Years",{"count":63,"type":64},100,"ESTIMATED","INTERVENTIONAL",[67],"NA","Neuroma-related pain is a frequent and disabling condition after limb trauma and amputation. Available treatments often provide short-lasting or insufficient analgesia. The SILENCE-NEUROMA Trial is a multicenter, randomized, double-blind, active-controlled study designed to compare the efficacy and safety of botulinum toxin type A versus local anesthetic injection for the treatment of neuroma-related pain. The primary outcome is pain reduction at 8 weeks after treatment.",[70,71,72,73],"Pain Management","Pain","Phantom Limb Pain","Phantom Limb Pain After Amputation",[75,76,77,78,79,80,81],"Neuroma pain","Local anesthetic","Chronic pain","Limb trauma","Amputation","Botulinum toxin","Ultrasound-guided injection","NOT_YET_RECRUITING","2026-02-21",{"date":85,"type":86},"2026-02-25","ACTUAL",{"date":88,"type":64},"2026-02-15",{"date":90,"type":64},"2026-12-15",{"name":5,"class":6},1]