Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain

May 19, 2026 updated by: EPC Education s.r.o.

Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study

Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BVN ablation
Procedure: BVN ablation
intraosseal monopolar basivertebral nerve ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Oswestry Disability Index (ODI)
Time Frame: 3, 6, 12 months
Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
3, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) for Pain
Time Frame: 3,6,12 months
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
3,6,12 months
EQ-5D standardized questionnaire used to measure health-related quality of life
Time Frame: 3, 6 12 months
Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
3, 6 12 months
Global Rating of Change (GRC)
Time Frame: 3, 6 12 months
retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
3, 6 12 months
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Time Frame: 3, 6 12 months
Scale 0 - 30; where 0 (no pain and no limitations) and 30 (worst imaginable pain, no life enjoyment and total limitation in general activities)
3, 6 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EPC Education s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KS_EPCcz_2026/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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