EuroPainClinicsStudy XIr-Zj (EPCS XIr-Zj)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Back Pain
• Intervention / Treatment: Procedure: Lumbar medial branch cryo ablation neurotomy; Procedure: Lumbar medial branch radiofrequency ablation neurotomy; Procedure: Endoscopic denervation of fazet joint

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bardejov, Slovakia, 08501
    • MD, PhD, FIPP Rapcan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar medial branch cryoablation; 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; The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Experimental: Lumbar medial branch RF neurotomy; 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; The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Experimental: Lumbar fazet joint decapsulation; Lumbar facet joint decapsulation through an endoscopic approach	Procedure: Endoscopic denervation of fazet joint; The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Collaborators: Slovak Academy of Sciences
• Investigators: Study Chair: MD, PhD, FIPP Rapcan, MD, FIPP, R-Clinic Bardejov, Slovakia, 085 01

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 6146/2022/ODDZ-25513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: publishing results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No