Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection

Starting soon · Not applicable

Conditions studied: Pain Management, Pain, Phantom Limb Pain, Phantom Limb Pain After Amputation

In brief

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.

Key facts

Study ID

NCT07431944

Run by

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

People needed

100

Starts

2026-02-15

Expected to finish

2026-12-15

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Average pain intensity ≥4 on a 0-10 Numerical Rating Scale (NRS) during the week prior to screening
• Stable analgesic regimen for at least 14 days prior to enrollment
• Ability to provide written informed consent

You may not qualify if…

• 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
• Botulinum toxin treatment within the previous 4-6 months
• Planned surgical neuroma revision during the study period
• allergy or hypersensitivity to botulinum toxin or local anesthetics

Where it is running

• Superhumans War Trauma Center — Lviv, Ukraine

Full record on ClinicalTrials.gov

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