Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BVN ablation.
- Who it may be relevant to
- Registry conditions: Chronic Back Pain, Basivertebral Nerve Ablation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia, Slovakia, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study
Overview
Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.
Detailed description
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.
Interventions
- Procedure BVN ablation
intraosseal monopolar basivertebral nerve ablation
Primary outcome measures
- The Oswestry Disability Index (ODI) [Time frame: 6 weeks, and 3, 6, 12 months]
Secondary outcome measures (4)
- Numeric Rating Scale (NRS) for Pain [Time frame: 6 weeks, and 3,6,12 months]
- EQ-5D standardized questionnaire used to measure health-related quality of life [Time frame: 6 weeks, and 3, 6 12 months]
- Pain, Enjoyment of Life, and General Activity (PEG) Assessment [Time frame: 6 weeks, and 3, 6 12 months]
- Global Rating of Change (GRC) [Time frame: 6 weeks, and 3, 6 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- EuroPainClinics Praha a.s — Prague
Slovakia · 1 center
- Poliklinika Terasa — Košice
Sweden · 1 center
- Europainclinics Sweden — Umeå
Identifiers
NCT: NCT07559890 · KS_EPCcz_2026/001