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

Sponsor

Europainclinics z.ú. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04684303

Collaborator

Brno University Hospital (Other), Slovak Academy of Sciences (Other), Pavol Jozef Safarik University (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Back Pain	Procedure: Lumbar medial branch radiofrequency ablation neurotomy Procedure: Lumbar medial branch cryo ablation neurotomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective observational clinical trialProspective observational clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m [6 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 6m [6 months follow-up]
VAS 10 point measurement
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m [12 months follow-up]
VAS 10 point measurement
Oswestry disability index (ODI) 6m [6 months follow-up]
The ODI self-administered questionnaire measuring 0-100 scale
Oswestry disability index (ODI) 12m [12 months follow-up]
The ODI self-administered questionnaire measuring 0-100 scale

Secondary Outcome Measures

Before procedure drug usage [before procedure]
drug usage
Postprocedural drug usage [12 months follow-up]
drug usage
Appearance and rate of complications related to procedure [12 months follow-up]
complications
Dose of radiation exposure [12 months follow-up]
complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EuroPainClinics	Bardejov		Slovakia	085 01

Sponsors and Collaborators

Europainclinics z.ú.
Brno University Hospital
Slovak Academy of Sciences
Pavol Jozef Safarik University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Europainclinics z.ú.

ClinicalTrials.gov Identifier:

NCT04684303

Other Study ID Numbers:

03595/2020/OZ-31

First Posted:

Dec 24, 2020

Last Update Posted:

Dec 30, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Study Results

No Results Posted as of Dec 30, 2020