Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
intraosseal monopolar basivertebral nerve ablation
EuroPainClinics Praha a.s
Prague, Czechia
RECRUITINGPoliklinika Terasa
Košice, Slovakia
NOT_YET_RECRUITINGEuropainclinics Sweden
Umeå, Sweden
NOT_YET_RECRUITINGThe Oswestry Disability Index (ODI)
Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
Time frame: 6 weeks, and 3, 6, 12 months
Numeric Rating Scale (NRS) for Pain
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
Time frame: 6 weeks, and 3,6,12 months
EQ-5D standardized questionnaire used to measure health-related quality of life
Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
Time frame: 6 weeks, and 3, 6 12 months
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
Time frame: 6 weeks, and 3, 6 12 months
Global Rating of Change (GRC)
retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
Time frame: 6 weeks, and 3, 6 12 months
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