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.
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Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)
Timeframe: Baseline (prior to injection) and Week 8 (56 ± 7 days) after injection