Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

30 de mayo de 2026 actualizado por: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

Ultrasound-Guided Platelet-Rich Plasma Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Controlled Study

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Dmytro Dmytriiev, PhD.Professor
  • Número de teléfono: +380674309449
  • Correo electrónico: mddmytriiev@gmail.com

Ubicaciones de estudio

  • Ucrania
      • Kyiv, Ucrania, 03143
        • Feofaniya Clinical Hospital
        • Contacto:
          • Andrii Khomenko, MD
          • Número de teléfono: +380937635858
          • Correo electrónico: farmen@ukr.net
      • Vinnytsia, Ucrania, 21000
        • Vinnitsya university hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: PRP Injection Around Neuroma
Ultrasound-guided perineuroma platelet-rich plasma (PRP) injection performed for treatment of chronic neuroma pain after combat-related amputation. PRP will be prepared using autologous blood and injected under sterile conditions around the ultrasound-confirmed painful neuroma.
Biológico: 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.
Comparador activo: Local Anesthetic Injection
Ultrasound-guided perineuroma local anesthetic injection performed for treatment of chronic neuroma pain after combat-related amputation under sterile conditions around the ultrasound-confirmed painful neuroma.
Droga: 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.
Otros nombres:
  • Lidocaína
  • Bupivacaína

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Periodo de tiempo: Baseline to 12 weeks after injection

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." Change from baseline will be analyzed.

Scale Information:

Numeric Rating Scale (NRS)

Minimum Value:

0

Maximum Value:

10 Interpretation: Higher scores indicate greater neuroma pain intensity and worse clinical outcomes.
Baseline to 12 weeks after injection

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
Periodo de tiempo: Baseline to 12 and 24 weeks

Neuropathic pain characteristics will be assessed using the painDETECT Questionnaire (PD-Q), a validated patient-reported screening tool designed to identify neuropathic pain features. The questionnaire evaluates pain quality, sensory symptoms, pain pattern, and radiation of pain. Total scores range from -1 to 38, with higher scores indicating a greater likelihood and severity of neuropathic pain.

Scale Information:

painDETECT Questionnaire (PD-Q)

Minimum Value:

1

Maximum Value:

38

Interpretation:

Higher scores indicate more pronounced neuropathic pain characteristics and a greater likelihood of neuropathic pain.

Clinical Interpretation:

≤12 = Neuropathic pain unlikely 13-18 = Ambiguous result

≥19 = Neuropathic pain likely
Baseline to 12 and 24 weeks
Residual Limb Pain Intensity
Periodo de tiempo: Baseline to 12 and 24 weeks

Residual limb pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average residual limb pain during the previous 7 days on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."

Scale Information:

Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate greater residual limb pain intensity and worse clinical outcomes.
Baseline to 12 and 24 weeks
Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time
Periodo de tiempo: Baseline to 12 and 24 weeks

Prosthesis tolerance will be assessed by measuring the average daily duration of prosthesis use reported by the participant. Prosthesis wearing time reflects the participant's ability to comfortably use the prosthesis during daily activities and rehabilitation.

Measurement:

Average daily prosthesis wearing time

Unit of Measure:

Hours per day (hours/day)

Minimum Value:

0 hours/day

Maximum Value:

24 hours/day

Interpretation:

Higher values indicate better prosthesis tolerance and greater successful adaptation to prosthetic use.
Baseline to 12 and 24 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Analgesic Consumption Assessed as Oral Morphine Equivalent Daily Dose (OMEDD)
Periodo de tiempo: Baseline to 24 weeks

Analgesic consumption will be assessed by calculating the total daily opioid use and converting all opioid medications into Oral Morphine Equivalent Daily Dose (OMEDD) using established conversion factors. The average daily opioid requirement will be recorded throughout the study period.

Measurement:

Oral Morphine Equivalent Daily Dose (OMEDD)

Unit of Measure:

Milligrams per day (mg/day)

Minimum Value:

0 mg/day

Maximum Value:

No predefined maximum value Interpretation: Higher values indicate greater analgesic requirements and potentially more severe pain.
Baseline to 24 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ukrainian Society of Regional Anesthesia and Pain Therapy

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de diciembre de 2026

Finalización primaria (Estimado)

15 de diciembre de 2026

Finalización del estudio (Estimado)

15 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

23 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2026

Publicado por primera vez (Actual)

3 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 07v21052026
  • USRA (Otro identificador: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data including demographic characteristics, ultrasound findings, chronic neuroma pain intensity scores, neuropathic pain assessments, phantom limb pain measures, residual limb pain outcomes, prosthesis tolerance assessments, analgesic consumption, adverse events, and follow-up clinical evaluations collected during the study will be available for sharing. The study protocol, statistical analysis plan, and analytic code may also be shared upon reasonable request.

Marco de tiempo para compartir IPD

Beginning 6 months after publication of the primary study results and ending 5 years after publication.

Criterios de acceso compartido de IPD

De-identified individual participant data and supporting study documents will be available to qualified researchers, clinicians, and academic institutions upon reasonable request to the study investigators. Shared materials may include demographic data, ultrasound findings, pain assessments, follow-up outcomes, study protocol, statistical analysis plan, and analytic code. Requests will be reviewed for scientific validity, ethical compliance, and data protection considerations. Data access will be provided through secure institutional communication and data-sharing agreements when applicable.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir