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.
Age ≥18 years
History of limb trauma and/or limb amputation at least 3 months prior to enrollment
Clinical diagnosis of neuroma-related pain with focal tenderness and positive - - Tinel sign
Imaging confirmation of neuroma by ultrasound or MRI
Chronic pain condition unrelated to neuroma that predominates clinical symptoms
infection at or near the planned injection site
Known neuromuscular junction disorders (e.g., myasthenia gravis)
Pregnancy or breastfeeding
Single group
Botulinium toxin type A injection
DrugA 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
DrugA 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.
Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)
Description Neuroma-related pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain. The outcome measure is the mean change in NRS score from baseline (pre-injection assessment) to Week 8 following injection. Higher NRS scores indicate greater pain intensity. Negative values reflect improvement (pain reduction). Between-group differences (botulinum toxin type A versus local anesthetic) will be analyzed.
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