Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation

NCT07626983 | Not Yet Recruiting

• 2 other identifiers: 2205v0123052026UARA-NEUROQUIET
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with combat-related amputations frequently experience persistent neuroma pain that may interfere with rehabilitation, prosthesis use, sleep, mobility, and quality of life. Current treatment options often provide only temporary relief. This study aims to compare two ultrasound-guided injection approaches for chronic neuroma pain after combat-related amputation: botulinum toxin type A and local anesthetic injection. Participants will be randomly assigned to receive one of the two treatments. Pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes will be evaluated during follow-up visits over a 24-week period. The goal of the study is to determine whether botulinum toxin type A provides longer-lasting pain reduction and improved functional recovery compared with local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.

Conditions

Chronic Pain Due to Injury; Neural Injury; Neuroma of Upper Limb; Combat Related Symptoms; Neuroma of Lower Limb

Keywords

Neuroma pain; Combat-related amputation; Botulinum toxin type A; Local anesthetic injection; Ultrasound-guided injection; Phantom limb pain; Residual limb pain; Neuropathic pain; Military trauma; Chronic post-amputation pain; Ultrasound-guided pain intervention

Outcome Measures

Primary Outcomes (1)

• Change in neuroma pain intensity measured

  Assessment of change in average neuroma pain intensity using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) following ultrasound-guided injection treatment.

  Baseline to 12 weeks after intervention

Secondary Outcomes (6)

• Residual Limb Pain Intensity Assessed Using the Numeric Rating Scale (NRS)

  Baseline to 24 weeks

• Pain Catastrophizing

  Baseline, 3 months, 6 months, and 12 months after amputation.

• Prosthesis Tolerance Assessed Using the Prosthesis Evaluation Questionnaire (PEQ) - Utility and Satisfaction Domains

  Baseline to 24 weeks

• Analgesic Consumption

  Baseline to 24 weeks

• Patient Global Impression of Change (PGIC)

  Week 12 and Week 24

Other Outcomes (5)

• Sleep Disturbance

  Baseline to 24 weeks

• Functional Mobility

  Baseline to 24 weeks

• Need for Repeat Intervention

  Up to 24 weeks

Study Arms (2)

Botulinum Toxin Type A

EXPERIMENTAL

Ultrasound-guided perineuroma injection of botulinum toxin type A for persistent neuroma pain after combat-related amputation.

Drug: Botulinum Toxin Type A (BoNT-A)

Local Anesthetic

ACTIVE COMPARATOR

Ultrasound-guided perineuroma injection of local anesthetic for persistent neuroma pain after combat-related amputation.

Drug: Local Anesthetic Solution

Interventions

Botulinum Toxin Type A (BoNT-A) DRUG

Ultrasound-guided perineuroma injection of botulinum toxin type A for treatment of persistent neuroma pain after combat-related amputation.

Botulinum Toxin Type A

Local Anesthetic Solution DRUG

Ultrasound-guided perineuroma injection of local anesthetic for treatment of persistent neuroma pain after combat-related amputation.

Local Anesthetic

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years
• Combat-related limb amputation
• Persistent neuroma pain lasting ≥3 months
• Ultrasound-confirmed neuroma
• Positive Tinel sign over the neuroma
• Average pain intensity ≥4/10 on the Numeric Rating Scale (NRS)
• Stable analgesic regimen for at least 14 days before enrollment
• Ability to provide written informed consent

You may not qualify if:

• Active infection at the injection site
• Previous botulinum toxin injection within 6 months
• Previous neuroma surgery within 3 months
• Severe uncontrolled psychiatric disorder
• Coagulopathy or anticoagulant therapy contraindicating injection
• Known allergy to botulinum toxin or local anesthetics
• Severe uncontrolled systemic disease
• Inability to complete study follow-up or questionnaires

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (2)

Feofaniya Clinical Hospital

Kyiv, Vinnytsia Oblast, 03143, Ukraine

Location

Vinnitsya university hospital

Vinnitsa, 21000, Ukraine

Location

Related Publications (1)

• Climent JM, Mondejar-Gomez F, Rodriguez-Ruiz C, Diaz-Llopis I, Gomez-Gallego D, Martin-Medina P. Treatment of Morton neuroma with botulinum toxin A: a pilot study. Clin Drug Investig. 2013 Jul;33(7):497-503. doi: 10.1007/s40261-013-0090-0.

  PMID: 23740337 RESULT

MeSH Terms

Conditions

Phantom Limb; Neuralgia

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; mddmytriiev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators performing outcome assessment, and data analysts will remain blinded to treatment allocation throughout the study period. Study medications will be prepared in identical syringes to maintain masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: 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 for persistent neuroma pain after combat-related amputation. The study will use a parallel-group design in which each participant receives only one assigned intervention throughout the study period. Participants, outcome assessors, and data analysts will remain blinded to treatment allocation.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 4, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.
• Access Criteria: De-identified individual participant data and supporting documents will be available to qualified researchers upon reasonable request to the study investigators. Requests will be reviewed for scientific validity and compliance with institutional and ethical requirements.

Locations

UA (2)