EuroPainClinicsStudy XIr-Zj

Back Pain Clinical Trial

— EPCS XIr-Zj  

Official title:

EuroPainClinicsStudy XIr-Zj (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05813639
• Other study ID #: 6146/2022/ODDZ-25513
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2023
• Source: Europainclinics z.ú.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients aged between 20 and 80
• positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application
• positive patient history of 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 tests 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

Related Conditions & MeSH terms

• Back Pain

Intervention

Procedure:
• Lumbar medial branch cryo ablation neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
• Lumbar medial branch radiofrequency ablation neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
• Endoscopic denervation of fazet joint
The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach

Locations

Country	Name	City	State
Slovakia	MD, PhD, FIPP Rapcan	Bardejov

Sponsors (2)

Lead Sponsor	Collaborator
Europainclinics z.ú.	Slovak Academy of Sciences

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m	EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression	6 months follow-up
Primary	Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 12m	EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression	12 months follow-up
Primary	Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m	Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement	6 months follow-up
Primary	Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m	Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement	12 months follow-up
Primary	Oswestry Disability Index (ODI) 12m	The ODI self-administered questionnaire measuring 0-100 scale	12 months follow-up
Primary	Oswestry Disability Index (ODI) 6m	The ODI self-administered questionnaire measuring 0-100 scale	6 months follow-up