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NCT07624877
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Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation

Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

View on ClinicalTrials.gov

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.

Official title: Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05-27

Completion Date

2026-12-15

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

Botulinum toxin type A injection

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.

Locations (2)

Feofaniya Clinical Hospital

Kyiv, Ukraine

Vinnitsya university hospital

Vinnytsia, Вінницька, Ukraine