EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)

Last updated: December 29, 2020
Sponsor: Europainclinics z.ú.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04684303
03595/2020/OZ-31
  • Ages 20-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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, fullyunderstood the clinical trial details and signed the informed consent form

Exclusion

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

Study Design

Total Participants: 150
Study Start date:
January 01, 2021
Estimated Completion Date:
January 01, 2023

Study 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.

Connect with a study center

  • EuroPainClinics

    Bardejov, 085 01
    Slovakia

    Active - Recruiting

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