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CompletedNCT07507565Updated May 26, 2026

Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs Thermal Facet Ablation.

An interventional study of Thermal facet ablation and Vertebroplasty in Vertebral Compression Fracture, sponsored by Szeged University. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Szeged University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Dec 2020, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Study design: A prospective randomized study is performed and cases are selected where the indication for surgery is a vertebral compression fracture.

Object: To assess outcomes and complications in patients undergoing vertebroplasty, kyphoplasty and thermal facet ablation for vertebral compression.

02

Conditions studied

  • Vertebral Compression Fracture
03

In context

Lead sponsor

Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >18 years-old
  • Subjects who are able to give informed consent and to understand and comply with study requirements.
  • Predominantly axial back and low back pain ≥ 1 month in duration with no radicular pain below the knee that failed to conservative therapy.
  • Subjects who have chronic back pain attributed to vertebral compression fractures (AO Spine A1 or A2 fractures) based on clinical evaluation (CT or MRI).

Exclusion criteria

Exclusion Criteria:

  • Subjects who decline to provide written consent or follow-up.
  • Subjects who are pregnant.
  • Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.
  • Subjects who have an active systemic or local infection.
  • Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).
  • Secondary gain (i.e., ongoing litigation, worker's compensation or other financial incentives)
  • Psychopathology including depression, somatization or poor coping skills
  • Physical factors including non-sedentary lifestyle, e.g.; morbid obesity (BMI > 35kg/m2).
  • History of previous Radiofrequency Ablation at the same level(s) in the previous 12 months.
  • History of previous Vertebroplasty at the same level(s) in the previous 12 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • Active comparator
    thermal facet ablation

    A minimally invasive procedure designed to alleviate chronic back pain originating from the facet joints using radiofrequency energy. This process, known as denervation, aims to provide long-term pain relief and improve physical function without affecting motor nerves.

    Procedure: Thermal facet ablation

  • Active comparator
    Vertebroplasty

    Minimally invasive image-guided procedure with percutaneous injection of bone cement into the fractured vertebral body. The cement hardens quickly, stabilizing the fracture, strengthening the vertebra, and providing rapid pain relief by preventing further micro-movements at the fracture site.

    Procedure: Vertebroplasty · Procedure: Kyphoplasty

Interventions

  • ProcedureThermal facet ablation

    A minimally invasive procedure that uses heat radiofrequency) to target and disable the sensory nerves around damaged facet joints in the spine, stopping pain signals to the brain for relief from chronic back pain, stiffness, and limited mobility, with minimal scarring and quick recovery, often done with local anesthetic.

  • ProcedureVertebroplasty

    A minimally invasive procedure to treat painful spinal compression fractures, by injecting special bone cement (polymethyl methacrylate) into the fractured vertebra using a needle guided by imaging (fluoroscopy) for stabilization and pain relief.

  • ProcedureKyphoplasty

    A minimally invasive spine procedure to treat painful vertebral compression fractures by using a balloon to restore height to a collapsed vertebra, then filling the space with bone cement. The surgeon inserts a tube, inflates a balloon to create space and realign the bone, removes the balloon, and injects cement, all guided by real-time X-rays (fluoroscopy).

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) Pain Score 2-day After Procedure, VAS Score Evaluation 0: No pain 1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain

    Time frame: 2 days after the treatment

Secondary outcomes

  1. Visual Analog Scale (VAS) 2 months

    Visual Analog Scale (VAS) Pain Score 2-months After Procedure VAS Score Evaluation 0: No pain 1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain

    Time frame: 2 months after the procedure

Other outcomes

  1. Visual Analog Scale (VAS) Pain Score 6-month

    Visual Analog Scale (VAS) Pain Score 6 months After Procedure VAS Score Evaluation 0: No pain 1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain

    Time frame: 6 months after the procedure

07

Study locations

1 site
  • Department of Neurosurgery
    Szeged, Csongrád megye 6725, Hungary
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07507565
Lead sponsor
Szeged University
Responsible party
Sponsor
First posted
Apr 2, 2026
Start date
Dec 15, 2020
Primary completion
Jul 31, 2025
Completion
Apr 20, 2026
Last update
May 26, 2026

Study contacts

Tamás Tóth, MD
principal investigator · Szeged University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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