NCT07559890

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
May 2026May 2029

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

July 31, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

April 24, 2026

Last Update Submit

July 30, 2026

Conditions

Chronic Back PainBasivertebral Nerve Ablation

Keywords

chronic back painbasivertebral nerve ablationradiofrequency

Outcome Measures

Primary Outcomes (1)

  • The Oswestry Disability Index (ODI)

    Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.

    6 weeks, and 3, 6, 12 months

Secondary Outcomes (4)

  • Numeric Rating Scale (NRS) for Pain

    6 weeks, and 3,6,12 months

  • EQ-5D standardized questionnaire used to measure health-related quality of life

    6 weeks, and 3, 6 12 months

  • Pain, Enjoyment of Life, and General Activity (PEG) Assessment

    6 weeks, and 3, 6 12 months

  • Global Rating of Change (GRC)

    6 weeks, and 3, 6 12 months

Study Arms (1)

BVN ablation

EXPERIMENTAL
Procedure: BVN ablation

Interventions

BVN ablationPROCEDURE

intraosseal monopolar basivertebral nerve ablation

BVN ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

EuroPainClinics Praha a.s

Prague, 17000, Czechia

RECRUITING

Poliklinika Terasa

Košice, 04001, Slovakia

NOT YET RECRUITING

Europainclinics Sweden

Umeå, 90137, Sweden

NOT YET RECRUITING

Central Study Contacts

Michal Matias, MD, FIPP

CONTACT

+420602246127matias@europainclinics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

April 30, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Last Updated

July 31, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)SE(1)CZ(1)