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

Официальное название

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

Обзор

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.

Подробное описание

Chronic neuroma pain is a common and disabling complication following combat-related limb trauma and amputation. Persistent neuroma pain may contribute to residual limb pain, phantom limb pain, impaired prosthesis tolerance, reduced mobility, sleep disturbance, and decreased quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a promising treatment option because of its potential effects on peripheral nociceptive signaling, neurogenic inflammation, and neuropathic pain modulation.

However, the optimal injection technique for botulinum toxin administration in painful neuromas remains unclear. Two commonly used approaches include direct intraneuroma injection and perineuroma injection surrounding the neuroma. Intraneuroma injection may provide more direct pharmacological modulation of pathological nerve tissue, whereas perineuroma injection may reduce the risk of mechanical nerve injury while still targeting peripheral sensitization mechanisms.

This prospective multicenter study is designed to evaluate the feasibility, safety, and clinical outcomes associated with intraneuroma and perineuroma ultrasound-guided botulinum toxin type A injection techniques in patients with chronic neuroma pain after combat-related amputation.

Patients with ultrasound-confirmed painful neuromas will undergo ultrasound-guided botulinum toxin type A injection using one of the two injection techniques according to local clinical practice and physician decision-making. Clinical follow-up will include assessment of neuroma pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, patient-reported improvement, and adverse events.

The study aims to improve understanding of ultrasound-guided botulinum toxin injection strategies for chronic neuroma pain and to identify potential differences in safety and clinical effectiveness between intraneuroma and perineuroma approaches in patients with combat-related amputations.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Change in chronic neuroma pain intensity [Срок оценки: Baseline to 12 weeks after injection]

Вторичные конечные точки (3)

• Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q) [Срок оценки: Baseline to 12 and 24 weeks]
• Residual Limb Pain Intensity [Срок оценки: Baseline to 12 and 24 weeks]
• Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time [Срок оценки: Baseline, 3 months, 6 months, and 12 months after amputation or intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Украина · 2 центра

• Feofaniya Clinical Hospital — Kyiv
• Vinnitsya university hospital — Vinnytsia

Публикации

• 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

Идентификаторы

NCT: NCT07624877 · 092026v25052026 · USRA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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