EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)

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

Detailed Description
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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.

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

Conditions
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Back Pain

Intervention / Treatment
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* Procedure: Lumbar medial branch radiofrequency ablation neurotomy
* Procedure: Lumbar medial branch cryo ablation neurotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective observational clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar medial branch RF neurotomy<br>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<br>* Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy<br>|
| Experimental: Lumbar medial branch cryoablation<br>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<br>* Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy<br>|

What is the study measuring?
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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 |