Clinical trial NCT04684303: EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)
Official title: EuroPainClinicsStudy XI (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: Slovak Academy of Sciences
name: Pavol Jozef Safarik University
First posted: 2020-12-24
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective observational clinical trial
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
timeFrame: 6 months follow-up
measure: Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
timeFrame: 12 months follow-up
measure: Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
timeFrame: 6 months follow-up
measure: Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m
timeFrame: 12 months follow-up
measure: Oswestry disability index (ODI) 6m
timeFrame: 6 months follow-up
measure: Oswestry disability index (ODI) 12m
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Before procedure drug usage
timeFrame: before procedure
measure: Postprocedural drug usage
timeFrame: 12 months follow-up
measure: Appearance and rate of complications related to procedure
timeFrame: 12 months follow-up
measure: Dose of radiation exposure
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Bardejov
country: Slovakia
facility: EuroPainClinics
Study officials:
References: