Trials / Unknown
UnknownNCT04684303
EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)
EuroPainClinicsStudy XI (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- EPC Education s.r.o. · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Lumbar medial branch radiofrequency ablation neurotomy | Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy |
| PROCEDURE | Lumbar medial branch cryo ablation neurotomy | Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2022-01-01
- Completion
- 2023-01-01
- First posted
- 2020-12-24
- Last updated
- 2020-12-30
Locations
1 site across 1 country: Slovakia
Source: ClinicalTrials.gov record NCT04684303. Inclusion in this directory is not an endorsement.