NCT07431944

Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection

SILENCE-NEUROMA Trial: Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection in a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Neuroma pain following limb trauma or amputation is characterized by focal neuropathic pain, trigger-point tenderness, and significant functional impairment. Local anesthetic injections are commonly used for diagnostic and therapeutic purposes but typically provide only transient relief. Botulinum toxin type A has demonstrated analgesic properties through inhibition of neurotransmitter release and neurogenic inflammation, potentially offering longer-lasting pain relief. This multicenter, randomized, double-blind, active-controlled trial will enroll adults with clinically and imaging-confirmed neuroma-related pain persisting for at least 3 months after limb trauma or amputation. Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided botulinum toxin type A injection or ultrasound-guided local anesthetic injection using an identical technique and volume. Participants will be followed for 24 weeks. Pain intensity will be assessed using a numerical rating scale at predefined intervals. Secondary outcomes include responder rates, neuropathic pain characteristics, pain interference, functional outcomes, analgesic consumption, durability of pain relief, and safety. The study aims to provide high-quality evidence to guide interventional pain management strategies for neuroma-related pain.

Conditions

• Pain Management
• Pain
• Phantom Limb Pain
• Phantom Limb Pain After Amputation

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-02-15
• Completion: 2026-12-15
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Ukraine