EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints) (EPCS XI)

EuroPainClinicsStudy XI (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: Unknown
• Conditions: Back Pain
• Intervention / Treatment: Procedure: Lumbar medial branch radiofrequency ablation neurotomy; Procedure: Lumbar medial branch cryo ablation neurotomy

Detailed Description

Description of the clinical state:

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 (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bardejov, Slovakia, 085 01
    • Recruiting
    • Europainclinics
    • Contact: Rapcan Robert, MD FIPP; Phone Number: +421 948 602 510; Email: rapcan@europainclinics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:dsds

• patients aged between 20 and 80
• positive two medial branch nerve blocks with pain relief over 80% during the first 12hours after nerve block application
• positive patient history for 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 test 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar medial branch RF neurotomy; Procedure lumbar medial branch RF neurotomy By raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before procedure, 3 months, 6 months, 12 months and 24 months after procedure Repeated cryoablation ablation procedures is allowed (when VAS will be > 4 )	Procedure: Lumbar medial branch radiofrequency ablation neurotomy; Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Experimental: Lumbar medial branch cryoablation; Procedure lumbar medial branch cryoablation Decreasing the temperature of the electrode to - 85 C for 120 seconds in two cycles. Follow-up: before procedure, 3 months, 6 months, 12 months and 24 months after procedure Repeated cryoablation ablation procedures is allowed (when VAS will be =/> 4 )	Procedure: Lumbar medial branch cryo ablation neurotomy; Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy

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	VAS 10 point measurement	6 months follow-up
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m	VAS 10 point measurement	12 months follow-up
Oswestry disability index (ODI) 6m	The ODI self-administered questionnaire measuring 0-100 scale	6 months follow-up
Oswestry disability index (ODI) 12m	The ODI self-administered questionnaire measuring 0-100 scale	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Before procedure drug usage	drug usage	before procedure
Postprocedural drug usage	drug usage	12 months follow-up
Appearance and rate of complications related to procedure	complications	12 months follow-up
Dose of radiation exposure	complications	12 months follow-up

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Collaborators: Brno University Hospital; Pavol Jozef Safarik University; Slovak Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 03595/2020/OZ-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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