EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)

Not Applicable

• Conditions: Back Pain
• Interventions: Procedure: Lumbar medial branch cryo ablation neurotomy; Procedure: Lumbar medial branch radiofrequency ablation neurotomy

• Registration Number: NCT04684303
• Lead Sponsor: Europainclinics z.ú.

Brief Summary

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

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 Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-24
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30
• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar medial branch cryoablation	Lumbar medial branch cryo ablation neurotomy	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 )
Lumbar medial branch RF neurotomy	Lumbar medial branch radiofrequency ablation 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 )

Primary Outcome Measures

Name	Time	Method
Oswestry disability index (ODI) 12m	12 months follow-up	The ODI self-administered questionnaire measuring 0-100 scale
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 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 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

EuroPainClinics; 🇸🇰 Bardejov, Slovakia