Ultrasound-Guided Platelet-Rich Plasma Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation

Официальное название

Ultrasound-Guided Platelet-Rich Plasma Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Controlled 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. Current treatment approaches often provide only temporary pain relief. Platelet-rich plasma (PRP) has emerged as a potential regenerative treatment option because of its possible effects on tissue healing, neuroinflammation, and peripheral nerve irritation. However, its role in the treatment of chronic neuroma pain after amputation remains unclear. This prospective multicenter controlled study aims to compare ultrasound-guided PRP injection around the neuroma with ultrasound-guided local anesthetic injection in patients with chronic neuroma pain after combat-related amputation. Participants will undergo one of the two injection treatments and will be followed over time to evaluate changes in pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes. The goal of the study is to evaluate the safety, feasibility, and potential clinical effectiveness of PRP injection for chronic neuroma pain following combat-related amputation.

Подробное описание

Chronic neuroma pain is a frequent 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, sleep disturbance, reduced mobility, and decreased quality of life. Conventional treatment strategies, including local anesthetic injections, often provide only temporary pain relief and limited long-term functional improvement.

Platelet-rich plasma (PRP) has emerged as a potential regenerative treatment option because of its possible effects on tissue repair, neuroinflammation, peripheral sensitization, and scar-related nerve irritation. PRP contains multiple growth factors and bioactive molecules that may support peripheral nerve healing and modulation of chronic neuropathic pain mechanisms. However, evidence regarding PRP treatment for chronic neuroma pain after combat-related amputation remains limited.

This prospective multicenter controlled study is designed to compare ultrasound-guided PRP injection around the neuroma with ultrasound-guided local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.

Patients with ultrasound-confirmed painful neuromas will undergo ultrasound-guided perineuroma injection using either PRP or local anesthetic according to the study protocol. All procedures will be performed under sterile conditions by clinicians experienced in ultrasound-guided pain interventions.

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 evaluate the safety, feasibility, and potential clinical effectiveness of PRP injection as a regenerative treatment strategy for chronic neuroma pain following combat-related amputation.

Вмешательства

• Биопрепарат Platelet-Rich Plasma (PRP) Injections
  Ultrasound-guided perineuroma platelet-rich plasma injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
• Препарат Local Anesthetic Injection
  Ultrasound-guided perineuroma local anesthetic injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.

Первичные конечные точки

• Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS) [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 to 12 and 24 weeks]

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
• Persistent pain interfering with rehabilitation, prosthesis use, or daily activities
• 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 PRP injection for neuroma pain within 6 months
• Previous neuroma surgery within 3 months
• Severe coagulopathy or platelet disorder
• Anticoagulant therapy contraindicating injection
• Active malignancy
• Severe uncontrolled systemic disease
• Known allergy to local anesthetics
• 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

Тройное слепое

Основная цель

Лечение

Центры проведения

Украина · 2 центра

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

Публикации

• Yu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011 Apr;121(4):176-80. doi: 10.3109/00207454.2010.544432. Epub 2011 Jan 19. PMID 21244302

Идентификаторы

NCT: NCT07624890 · 07v21052026 · USRA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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