Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection

NCT07431944 ↗

Not yet recruiting 100 enrolled Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start: 2026-02-15
Primary completion: 2026-02-15
Completion: 2026-12-15

Publications

Results Dmytriiev D, Liu W, Barsa M, Khomenko A, Strokan A, Pasquina PF, Cohen SP. Perineuromal hydrodissection for acute postamputation pain? An observational study in a time of war. Reg Anesth Pain Med. 2025 Feb 26:rapm-2024-106307. doi: 10.1136/rapm-2024-106307. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Other
Comparator	Bupivacaine	Other / unclassified	0.25 %	Other
Comparator	Bupivacaine	Other / unclassified	2 ml	Other
Comparator	Ropivacaine	Other / unclassified	0.2 %	Other
Comparator	Ropivacaine	Other / unclassified	2 ml	Other

Indications

No indication recorded.