Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain
Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation (BVNA) for Axial Low Back Pain treatment, including the method optimization.
Description of Clinical State:
The basivertebral nerve is a small nerve (or rather a nerve fiber) located within the vertebral bodies, responsible for transmitting pain signals from a degenerated disc. Basivertebral nerve ablation is a minimally invasive procedure consisting of the interruption of the basivertebral nerve fibers that conduct pain.
Description of interventional procedures:
The BVNA procedure is performed under sterile conditions in an interventional suite by an experienced physician under fluoroscopic (X-ray) guidance. Following local anesthesia of the skin and subcutaneous tissue, a working instrument (cannula) is inserted into the affected vertebral body, guided by the patient's individual anatomy and preoperative Magnetic Resonance Imaging (MRI) planning. Subsequently, a radiofrequency electrode is introduced into the central part of the vertebral body. Through this electrode, targeted thermal energy is applied, leading to the interruption of pain signal transmission from the basivertebral nerve. Both the temperature and the duration of the application are strictly controlled. The patient remains conscious or under light sedation throughout the procedure and is continuously monitored and questioned regarding any discomfort, particularly pain or sensations of heat. Upon completion of the procedure, the electrode and the working instrument are removed, the puncture site is treated with a sterile dressing, and the patient is typically discharged to home care after a brief postoperative observation period. During the follow-up period, the patient will be asked to complete standardized questionnaires (Numeric Rating Scale (NRS) for Pain; Pain, Enjoyment of Life, and General Activity (PEG) Assessment; Global Rating of Change (GRC); The Oswestry Disability Index (ODI); EQ-5D Standardized Questionnaire used to measure Health-related Quality of Life) assessing pain intensity, functional limitations, and quality of life at intervals of 6 weeks, and 3, 6, and 12 months post-procedure, and long-term (24 months and beyond) depending on capacity. The follow-up also includes a control MRI scan approximately 6 months after the procedure.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michal Matias, MD, FIPP
- Número de teléfono: +420602246127
- Correo electrónico: matias@europainclinics.com
Ubicaciones de estudio
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Prague, Chequia, 17000
- Reclutamiento
- EuroPainClinics Praha a.s
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Contacto:
- Michal Matias, MD, FIPP
- Número de teléfono: +420602246127
- Correo electrónico: matias@europainclinics.com
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Košice, Eslovaquia, 04001
- Aún no reclutando
- Poliklinika Terasa
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Contacto:
- Robert Rapčan, MD, FIPP
- Número de teléfono: +421948006267
- Correo electrónico: rapcan@europainclinics.com
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Umeå, Suecia, 90137
- Aún no reclutando
- Europainclinics Sweden
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Contacto:
- Robert Rapčan, MD, FIPP
- Número de teléfono: +421948006267
- Correo electrónico: rapcan@europainclinics.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Axial low back pain (with or without lateral component).
- Presence of Modic type I or II changes at ≥ 1 level.
- Age over 18 years.
- Duration of pain ≥ 6 months.
- Completion of full conservative management for ≥ 3 months.
- Medial Branch Block (MBB) test performed with negative results/ or Facet Denervation done with unsatisfactory outcome (less than 50% improvement) after positive MBB test.
Exclusion Criteria:
- Coagulation disorders.
- Platelet abnormalities.
- Lack of informed consent.
- Generalized solid tumor.
- Hematopoietic malignancy.
- Radicular pain.
- Alternative primary pain generators other than axial low back pain.
- Previous spinal surgery.
- Targeted level located above L3/L4
- Osteoporosis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: BVN ablation
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intraosseal monopolar basivertebral nerve ablation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Oswestry Disability Index (ODI)
Periodo de tiempo: 6 weeks, and 3, 6, 12 months
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Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
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6 weeks, and 3, 6, 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Numeric Rating Scale (NRS) for Pain
Periodo de tiempo: 6 weeks, and 3,6,12 months
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Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
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6 weeks, and 3,6,12 months
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EQ-5D standardized questionnaire used to measure health-related quality of life
Periodo de tiempo: 6 weeks, and 3, 6 12 months
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Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
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6 weeks, and 3, 6 12 months
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Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Periodo de tiempo: 6 weeks, and 3, 6 12 months
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Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
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6 weeks, and 3, 6 12 months
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Global Rating of Change (GRC)
Periodo de tiempo: 6 weeks, and 3, 6 12 months
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retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
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6 weeks, and 3, 6 12 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- KS_EPCcz_2026/001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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