EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    150
  • sponsor
    Europainclinics z.ú.
Updated on 29 January 2021

Summary

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

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.

Details
Condition Back Pain, Chronic Back Pain, Pain, Post-Surgical Pain, Pain (Pediatric), Pain, Chronic Back Pain, Post-Surgical Pain, Pain (Pediatric), backpain, backache
Treatment Lumbar medial branch radiofrequency ablation neurotomy, Lumbar medial branch cryo ablation neurotomy
Clinical Study IdentifierNCT04684303
SponsorEuropainclinics z.ú.
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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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
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