Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection (SILENCE-NEUROM)

February 21, 2026 updated by: Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ukraine
      • Lviv, Ukraine
        • Superhumans War Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum Toxin Type A
Single ultrasound-guided perineural injection of botulinum toxin type A (100 units diluted in 2.0 mL saline) administered around the confirmed neuroma using a standardized grid injection technique.
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.
Active Comparator: Local Anesthetic (Active Control)
Single ultrasound-guided perineural injection of local anesthetic (ropivacaine 0.2%, 2.0 mL or bupivacaine 0.25%, 2.0 mL) administered around the confirmed neuroma using the identical technique and volume.
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.

What is the study measuring?

Primary Outcome Measures

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

Description Neuroma-related pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain.

The outcome measure is the mean change in NRS score from baseline (pre-injection assessment) to Week 8 following injection.

Higher NRS scores indicate greater pain intensity. Negative values reflect improvement (pain reduction).

Between-group differences (botulinum toxin type A versus local anesthetic) will be analyzed.
Baseline (prior to injection) and Week 8 (56 ± 7 days) after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09v213022026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared due to patient privacy considerations and the sensitive nature of trauma-related clinical data. De-identified data may be made available upon reasonable request and approval by the study steering committee under a formal data use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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