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Active, Not Recruiting

NCT Number: NCT05813639

EuroPainClinicsStudy XIr-Zj

Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD, PhD, FIPP Rapcan

Bardejov, 08501, Slovakia

About this study

Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome.A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint. Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches. Description of interventional procedures: Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged between 20 and 80
  • positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application
  • positive patient history of facet joint pain
  • patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS >=5)
  • those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion criteria

  • patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
  • women with positive a pregnancy tests before the trial or who planned to become
  • pregnant within the following 3 years
  • other patients viewed as inappropriate by the staff
  • disagreement with participation in the study

Treatment and study plan

Lumbar medial branch cryo ablation neurotomy

Procedure

The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy

Lumbar medial branch radiofrequency ablation neurotomy

Procedure

The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy

Endoscopic denervation of fazet joint

Procedure

The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach

Primary outcomes

  1. Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 36m

    Time frame: 36 months follow-up

    EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

  2. Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 12m

    Time frame: 12 months follow-up

    EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

  3. Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m

    Time frame: 36 months follow-up

    Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m measured by VAS 10 point measurement

  4. Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m

    Time frame: 36 months follow-up

    Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m measured by VAS 10 point measurement

  5. Oswestry Disability Index (ODI) 12m

    Time frame: 12 months follow-up

    The ODI self-administered questionnaire measuring 0-100 scale

  6. Oswestry Disability Index (ODI) 36m

    Time frame: 36 months follow-up

    The ODI self-administered questionnaire measuring 0-100 scale

Sponsors and collaborators

Lead sponsor

EPC Education s.r.o.

Other

Collaborators

  • Slovak Academy of Sciences

Registry information

Official study title

EuroPainClinicsStudy XIr-Zj (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)

Acronym: EPCS XIr-Zj

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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