EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints) (EPCS XI)

Europainclinics z.ú.

Status: Unknown

Conditions: Back Pain

Treatments: Procedure: Lumbar medial branch radiofrequency ablation neurotomy; Procedure: Lumbar medial branch cryo ablation neurotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04684303

03595/2020/OZ-31

Details and patient eligibility

About

Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:dsds

• patients aged between 20 and 80
• 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:

• patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Lumbar medial branch RF neurotomy

Experimental group

Description:

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 )

Treatment:

Procedure: Lumbar medial branch radiofrequency ablation neurotomy

Lumbar medial branch cryoablation

Experimental group

Description:

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 )

Treatment:

Procedure: Lumbar medial branch cryo ablation neurotomy