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| Name | Class |
|---|---|
| Brno University Hospital | OTHER |
| Slovak Academy of Sciences | OTHER_GOV |
| Pavol Jozef Safarik University | OTHER |
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Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar medial branch RF neurotomy | Experimental | 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 ) |
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| Lumbar medial branch cryoablation | Experimental | 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 ) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar medial branch radiofrequency ablation neurotomy | Procedure | Procedure 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Before procedure drug usage | drug usage | before procedure |
| Postprocedural drug usage | drug usage | 12 months follow-up |
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Inclusion Criteria:dsds
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ladislav Kocan, MD PhD | Contact | +421557891110 | europainclinicsstudy@gmail.com | |
| Robert Rapcan, MD PhD FIPP | Contact | rapcan@europainclinics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EuroPainClinics | Recruiting | Bardejov | 085 01 | Slovakia |
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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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Prospective observational clinical trial
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| Lumbar medial branch cryo ablation neurotomy | Procedure | Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy |
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| Appearance and rate of complications related to procedure | complications | 12 months follow-up |
| Dose of radiation exposure | complications | 12 months follow-up |