EuroPainClinicsStudy XIr-Zj

NCT05813639 — Not applicable, Active not recruiting, 150 participants, EPC Education s.r.o.

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

RegistryNCT05813639, acronym EPCS XIr-Zj
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment150 (Actual)
SponsorEPC Education s.r.o. (Other); collaborators: Slovak Academy of Sciences
ConditionsBack Pain
InterventionsLumbar medial branch cryo ablation neurotomy, Lumbar medial branch radiofrequency ablation neurotomy, Endoscopic denervation of fazet joint (Procedure)
Datesstart 2023-04-02, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2023-04-14, last updated 2026-06-18
Locations1 site in Slovakia

Related Papers Related Patents Related Grants Related Experts
All trials for Back Pain All trials of Lumbar medial branch cryo ablation neurotomy All trials of Lumbar medial branch radiofrequency ablation neurotomy

-Summary

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

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Lumbar medial branch cryoablationExperimentalProcedure: Lumbar medial branch cryo ablation neurotomyLumbar medial branch cryoablation Procedure lumbar medial branch cryoablation Decreasing the electrode temperature to - 85 C for 120 seconds in two cycles. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure Repeated cryoablation ablation procedures are allowed (when VAS will be =/> 4 ) Procedure/Surgery: Lumbar medial branch cryo ablation neurotomy A procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar medial branch RF neurotomyExperimentalProcedure: Lumbar medial branch radiofrequency ablation neurotomyLumbar medial branch RF neurotomy Procedure lumbar medial branch RF neurotomy: Raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure. Repeated cryoablation ablation procedures are allowed (when VAS will be > 4 )
Lumbar fazet joint decapsulationExperimentalProcedure: Endoscopic denervation of fazet jointLumbar facet joint decapsulation through an endoscopic approach
  • 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

+Outcome measures

Primary outcomes

  • Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 36m [36 months follow-up]: EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
  • Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 12m [12 months follow-up]: EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
  • Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m [36 months follow-up]: Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m measured by VAS 10 point measurement
  • Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m [36 months follow-up]: Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m measured by VAS 10 point measurement
  • Oswestry Disability Index (ODI) 12m [12 months follow-up]: The ODI self-administered questionnaire measuring 0-100 scale
  • Oswestry Disability Index (ODI) 36m [36 months follow-up]: The ODI self-administered questionnaire measuring 0-100 scale

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
MD, PhD, FIPP RapcanBardejovSlovakia

+Publications

  • Results publication: Kocan L, Rapcan R, Mlaka J, Griger M, Poliak L, Lences P, Kovalicova L, Manik E, Sherdil N, Burianek M, Vaskova J. Comparative Effectiveness of Radiofrequency Ablation, Cryoablation, and Endoscopic Denervation for Lumbar Facet Pain: A Multicenter Trial. Spine (Phila Pa 1976). 2026 Jan 1;51(1):1-8. doi: 10.1097/BRS.0000000000005539. Epub 2025 Nov 4. PMID 41084911

+Investigators

  • MD, PhD, FIPP Rapcan, MD, FIPP, Study chair, R-Clinic Bardejov, Slovakia, 085 01