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