Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection

NCT07431944 | Not Yet Recruiting

• 1 other identifier: 09v213022026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management; Pain; Phantom Limb Pain; Phantom Limb Pain After Amputation

Keywords

Neuroma pain; Local anesthetic; Chronic pain; Limb trauma; Amputation; Botulinum toxin; Ultrasound-guided injection

Outcome Measures

Primary Outcomes (1)

• Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)

  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

Study Arms (2)

Botulinum Toxin Type A

EXPERIMENTAL

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

Local Anesthetic (Active Control)

ACTIVE COMPARATOR

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

Interventions

Botulinium toxin type A injection DRUG

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.

Botulinum Toxin Type A

Local Anesthesia DRUG

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.

Local Anesthetic (Active Control)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans): lead

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 39971386 RESULT

MeSH Terms

Conditions

Agnosia; Pain; Phantom Limb; Chronic Pain

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain, Postoperative; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; d.dmytriiev@superhumans.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 25, 2026
• Study Start: February 15, 2026
• Primary Completion: February 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)