EuroPainClinicsStudy XIr-Zj

NCT05813639 | Unknown DMC

• 1 other identifier: 6146/2022/ODDZ-25513
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Back Pain

Outcome Measures

Primary Outcomes (6)

• Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m

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

  6 months follow-up

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

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

  12 months follow-up

• Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m

  Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement

  6 months follow-up

• Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m

  Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement

  12 months follow-up

• Oswestry Disability Index (ODI) 12m

  The ODI self-administered questionnaire measuring 0-100 scale

  12 months follow-up

• Oswestry Disability Index (ODI) 6m

  The ODI self-administered questionnaire measuring 0-100 scale

  6 months follow-up

Study Arms (3)

Lumbar medial branch cryoablation

EXPERIMENTAL

Lumbar 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

Procedure: Lumbar medial branch cryo ablation neurotomy

Lumbar medial branch RF neurotomy

EXPERIMENTAL

Lumbar 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 )

Procedure: Lumbar medial branch radiofrequency ablation neurotomy

Lumbar fazet joint decapsulation

EXPERIMENTAL

Lumbar facet joint decapsulation through an endoscopic approach

Procedure: Endoscopic denervation of fazet joint

Interventions

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 cryoablation

Lumbar medial branch radiofrequency ablation neurotomy PROCEDURE

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

Lumbar medial branch RF 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

Lumbar fazet joint decapsulation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Europainclinics z.ú.: lead
• Slovak Academy of Sciences: collaborator

Study Sites (1)

MD, PhD, FIPP Rapcan

Bardejov, 08501, Slovakia

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• MD, PhD, FIPP Rapcan, MD, FIPP

  R-Clinic Bardejov, Slovakia, 085 01

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: sealed envelope, random software
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospectively randomized patients with positive facet joint syndrome

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 14, 2023
• Study Start: April 2, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)