Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain
Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Michal Matias, MD, FIPP
- Numéro de téléphone: +420602246127
- E-mail: matias@europainclinics.com
Lieux d'étude
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Košice, Slovaquie, 04001
- Pas encore de recrutement
- Poliklinika Terasa
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Contact:
- Robert Rapčan, MD, FIPP
- Numéro de téléphone: +421948006267
- E-mail: rapcan@europainclinics.com
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Umeå, Suède, 90137
- Pas encore de recrutement
- Europainclinics Sweden
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Contact:
- Robert Rapčan, MD, FIPP
- Numéro de téléphone: +421948006267
- E-mail: rapcan@europainclinics.com
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Prague, Tchéquie, 17000
- Recrutement
- EuroPainClinics Praha a.s
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Contact:
- Michal Matias, MD, FIPP
- Numéro de téléphone: +420602246127
- E-mail: matias@europainclinics.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: BVN ablation
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intraosseal monopolar basivertebral nerve ablation
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Oswestry Disability Index (ODI)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Numeric Rating Scale (NRS) for Pain
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- KS_EPCcz_2026/001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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