Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation (IN-PERI NEUROM)
Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dmytro Dmytriiev, PhD.Professor
- Número de teléfono: +380674309449
- Correo electrónico: mddmytriiev@gmail.com
Ubicaciones de estudio
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Kyiv, Ucrania, 03143
- Feofaniya Clinical Hospital
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Contacto:
- Andrii Khomenko, MD
- Número de teléfono: +380937635858
- Correo electrónico: farmen@ukr.net
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Вінницька
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Vinnytsia, Вінницька, Ucrania, 21000
- Vinnitsya university hospital
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Contacto:
- Дмитро Дмитрієв
- Número de teléfono: 0674309449
- Correo electrónico: mddmytriiev@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
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
- 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 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intraneuroma Botulinum Toxin Type A Injection
Ultrasound-guided direct intraneuroma injection of botulinum toxin type A for treatment of chronic neuroma pain after combat-related amputation.
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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.
Otros nombres:
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Experimental: Perineuroma Botulinum Toxin Injection
Ultrasound-guided perineuroma injection of botulinum toxin type A surrounding the neuroma for treatment of chronic neuroma pain after combat-related amputation.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in chronic neuroma pain intensity
Periodo de tiempo: Baseline to 12 weeks after injection
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
Periodo de tiempo: Baseline to 12 and 24 weeks
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Neuropathic pain characteristics will be assessed using the painDETECT Questionnaire (PD-Q), a validated self-administered questionnaire designed to identify and quantify neuropathic pain symptoms. The questionnaire evaluates sensory descriptors, pain course pattern, and pain radiation. Total scores range from -1 to 38. 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 = Uncertain neuropathic pain component ≥19 = Neuropathic pain likely |
Baseline to 12 and 24 weeks
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Residual Limb Pain Intensity
Periodo de tiempo: Baseline to 12 and 24 weeks
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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 ("no pain") to 10 ("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 pain outcomes. |
Baseline to 12 and 24 weeks
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Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months after amputation or intervention.
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Prosthesis tolerance will be assessed by measuring the average daily duration of prosthesis use reported by the participant. Average daily prosthesis wearing time will be recorded as the total number of hours the prosthesis is worn during a typical day. 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, greater comfort during use, and improved adaptation to the prosthesis. |
Baseline, 3 months, 6 months, and 12 months after amputation or intervention.
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Andrii Khomenko, MD, Feofaniya Clinical Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias De Tejido Nervioso
- Neoplasias de la vaina nerviosa
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor crónico
- Neuroma
- Aminoácidos, péptidos y proteínas
- Proteínas
- Factores biológicos
- Hidrolasas
- Enzimas
- Enzimas y coenzimas
- Toxinas botulínicas
- Metaloendopeptidasas
- Endopeptidasas
- Hidrolasas peptídicas
- Metaloproteasas
- Proteínas bacterianas
- Toxinas bacterianas
- Toxinas, biológicas
- Toxinas botulínicas tipo A
Otros números de identificación del estudio
- 092026v25052026
- USRA (Otro identificador: Ukranian Society of Regional Anesthesia and Pain Therapy)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Marco de tiempo para compartir IPD
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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