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
2023-04-02
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lumbar medial branch cryoablation
Lumbar medial branch cryoablation Procedure lumbar medial branch cryoablation Decreasing the electrode temperature to - 85 C for 120 seconds in two cycles. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure Repeated cryoablation ablation procedures are allowed (when VAS will be =/\> 4 ) Procedure/Surgery: Lumbar medial branch cryo ablation neurotomy A procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar medial branch cryo ablation neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar medial branch RF neurotomy
Lumbar medial branch RF neurotomy Procedure lumbar medial branch RF neurotomy: Raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure. Repeated cryoablation ablation procedures are allowed (when VAS will be \> 4 )
Lumbar medial branch radiofrequency ablation neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar fazet joint decapsulation
Lumbar facet joint decapsulation through an endoscopic approach
Endoscopic denervation of fazet joint
The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach
Interventions
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Lumbar medial branch cryo ablation neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Lumbar medial branch radiofrequency ablation neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
Endoscopic denervation of fazet joint
The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach
Eligibility Criteria
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Inclusion Criteria
* positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application
* positive patient history of 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 tests 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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Slovak Academy of Sciences
OTHER_GOV
Europainclinics z.ú.
OTHER
Responsible Party
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Principal Investigators
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MD, PhD, FIPP Rapcan, MD, FIPP
Role: STUDY_CHAIR
R-Clinic Bardejov, Slovakia, 085 01
Locations
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MD, PhD, FIPP Rapcan
Bardejov, , Slovakia
Countries
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References
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Kocan L, Rapcan R, Mlaka J, Griger M, Poliak L, Lences P, Kovalicova L, Manik E, Sherdil N, Burianek M, Vaskova J. Comparative Effectiveness of Radiofrequency Ablation, Cryoablation, and Endoscopic Denervation for Lumbar Facet Pain: A Multicenter Trial. Spine (Phila Pa 1976). 2025 Oct 14. doi: 10.1097/BRS.0000000000005539. Online ahead of print.
Other Identifiers
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6146/2022/ODDZ-25513
Identifier Type: -
Identifier Source: org_study_id
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