Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2021-01-01
2023-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 )
Lumbar medial branch radiofrequency ablation neurotomy
Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
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 )
Lumbar medial branch cryo ablation neurotomy
Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Interventions
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Lumbar medial branch radiofrequency ablation neurotomy
Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar medial branch cryo ablation neurotomy
Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Brno University Hospital
OTHER
Slovak Academy of Sciences
OTHER_GOV
Pavol Jozef Safarik University
OTHER
Europainclinics z.รบ.
OTHER
Responsible Party
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Locations
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EuroPainClinics
Bardejov, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Rapcan Robert, MD FIPP
Role: primary
Other Identifiers
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03595/2020/OZ-31
Identifier Type: -
Identifier Source: org_study_id