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Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection
Sponsor: Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Summary
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.
Official title: SILENCE-NEUROMA Trial: Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection in a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-02-15
Completion Date
2026-12-15
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Superhumans War Trauma Center
Lviv, Ukraine