Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation

NCT07624877 | Not Yet Recruiting

• 2 other identifiers: 092026v25052026USRA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with combat-related amputations frequently experience chronic neuroma pain that may interfere with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a potential treatment option for persistent neuroma pain; however, the optimal injection technique remains unclear. This prospective multicenter study aims to compare two ultrasound-guided botulinum toxin injection techniques for chronic neuroma pain after combat-related amputation: intraneuroma injection and perineuroma injection. Participants with ultrasound-confirmed painful neuromas will undergo one of the two injection approaches based on the treating physician's clinical decision and local practice. Pain intensity, neuropathic pain characteristics, phantom limb pain, prosthesis tolerance, functional outcomes, and adverse events will be evaluated during follow-up. The goal of the study is to evaluate the feasibility, safety, and potential clinical effectiveness of intraneuroma and perineuroma botulinum toxin type A injection techniques in patients with chronic neuroma pain following combat-related amputation.

Conditions

Chronic Pain; Neuroma; Botulinium Toxin-A; Combat Trauma

Keywords

Chronic neuroma pain; Combat-related amputation; Botulinum toxin type A; Intraneuroma injection; Perineuroma injection; Ultrasound-guided injection; Residual limb pain; Painful neuroma

Outcome Measures

Primary Outcomes (1)

• Change in chronic neuroma pain intensity

  Change in chronic neuroma pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average neuroma-related pain during the previous 7 days on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." The change from baseline NRS score will be calculated at each follow-up assessment. Scale Information: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate greater chronic neuroma pain intensity and worse clinical outcomes. Negative change from baseline indicates improvement.

  Baseline to 12 weeks after injection

Secondary Outcomes (3)

• Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)

  Baseline to 12 and 24 weeks

• Residual Limb Pain Intensity

  Baseline to 12 and 24 weeks

• Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time

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

Study Arms (2)

Intraneuroma Botulinum Toxin Type A Injection

EXPERIMENTAL

Ultrasound-guided direct intraneuroma injection of botulinum toxin type A for treatment of chronic neuroma pain after combat-related amputation.

Drug: Botulinum toxin type A injection

Perineuroma Botulinum Toxin Injection

EXPERIMENTAL

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

Drug: Botulinum toxin type A injection

Interventions

Botulinum toxin type A injection DRUG

Ultrasound-guided botulinum toxin type A injection performed for treatment of chronic neuroma pain after combat-related amputation. Two injection techniques will be evaluated: direct intraneuroma injection and perineuroma injection surrounding the neuroma. Procedures will be performed under sterile conditions using high-frequency musculoskeletal ultrasound guidance by clinicians experienced in ultrasound-guided pain interventions.

Also known as: Ultrasound-Guided Botulinum Toxin Injection

Intraneuroma Botulinum Toxin Type A Injection; Perineuroma Botulinum Toxin Injection

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
• Chronic neuroma pain lasting ≥3 months
• Ultrasound-confirmed painful neuroma
• Average neuroma pain intensity ≥4/10 on the Numeric Rating Scale
• Ability to undergo ultrasound-guided injection
• Stable analgesic regimen for at least 14 days before enrollment
• Ability to provide written informed consent

You may not qualify if:

• Active infection at or near the injection site
• Open wound preventing safe injection
• Previous botulinum toxin injection for neuroma pain within 6 months
• Previous neuroma surgery within 3 months
• Known allergy to botulinum toxin type A
• Coagulopathy or anticoagulation contraindicating injection
• Severe uncontrolled systemic disease
• Inability to complete follow-up assessments

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (2)

Feofaniya Clinical Hospital

Kyiv, 03143, Ukraine

Location

Vinnitsya university hospital

Vinnytsia, Вінницька, 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

Chronic Pain; Neuroma

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

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

Study Officials

• Andrii Khomenko, MD

  Feofaniya Clinical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; mddmytriiev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and statisticians analyzing study data will remain blinded to the injection technique group whenever feasible. Treating clinicians performing the ultrasound-guided procedures will not be blinded because of the technical differences between intraneuroma and perineuroma injection approaches.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: Participants will be assigned to one of two ultrasound-guided botulinum toxin type A injection technique groups: intraneuroma injection or perineuroma injection. The study uses a parallel-group design to compare feasibility, safety, and clinical outcomes between the two approaches. Treatment allocation will be based on local clinical practice and physician decision-making rather than randomization.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 3, 2026
• Study Start: May 27, 2026
• Primary Completion: May 27, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 3, 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.

Locations

UA (2)