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| Name | Class |
|---|---|
| Slovak Academy of Sciences | OTHER_GOV |
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Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar medial branch cryoablation | Experimental | 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 |
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| Lumbar medial branch RF neurotomy | Experimental | 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 ) |
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| Lumbar fazet joint decapsulation | Experimental | Lumbar facet joint decapsulation through an endoscopic approach |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar medial branch cryo ablation neurotomy | Procedure | The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 36m | EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression | 36 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 12m | Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m measured by VAS 10 point measurement | 36 months follow-up |
| Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m | Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m measured by VAS 10 point measurement | 36 months follow-up |
| Oswestry Disability Index (ODI) 12m | The ODI self-administered questionnaire measuring 0-100 scale | 12 months follow-up |
| Oswestry Disability Index (ODI) 36m | The ODI self-administered questionnaire measuring 0-100 scale | 36 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD, PhD, FIPP Rapcan, MD, FIPP | R-Clinic Bardejov, Slovakia, 085 01 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD, PhD, FIPP Rapcan | Bardejov | 08501 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41084911 | Derived | 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). 2026 Jan 1;51(1):1-8. doi: 10.1097/BRS.0000000000005539. Epub 2025 Nov 4. |
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publishing results
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospectively randomized patients with positive facet joint syndrome
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sealed envelope, random software
| Lumbar medial branch radiofrequency ablation neurotomy | Procedure | The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy |
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| Endoscopic denervation of fazet joint | Procedure | The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach |
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