Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 3
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BVN ablation
Intervention: BVN ablation (Procedure)