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

Primary Purpose

Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Lumbar medial branch radiofrequency ablation neurotomy
Lumbar medial branch cryo ablation neurotomy
Sponsored by
Europainclinics z.ú.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • EuroPainClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lumbar medial branch RF neurotomy

Lumbar medial branch cryoablation

Arm 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 )

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 )

Outcomes

Primary Outcome Measures

Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
VAS 10 point measurement
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m
VAS 10 point measurement
Oswestry disability index (ODI) 6m
The ODI self-administered questionnaire measuring 0-100 scale
Oswestry disability index (ODI) 12m
The ODI self-administered questionnaire measuring 0-100 scale

Secondary Outcome Measures

Before procedure drug usage
drug usage
Postprocedural drug usage
drug usage
Appearance and rate of complications related to procedure
complications
Dose of radiation exposure
complications

Full Information

First Posted
December 15, 2020
Last Updated
December 29, 2020
Sponsor
Europainclinics z.ú.
Collaborators
Brno University Hospital, Slovak Academy of Sciences, Pavol Jozef Safarik University
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1. Study Identification

Unique Protocol Identification Number
NCT04684303
Brief Title
EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)
Acronym
EPCS XI
Official Title
EuroPainClinicsStudy XI (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Europainclinics z.ú.
Collaborators
Brno University Hospital, Slovak Academy of Sciences, Pavol Jozef Safarik University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective observational clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbar medial branch RF neurotomy
Arm Type
Experimental
Arm 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 )
Arm Title
Lumbar medial branch cryoablation
Arm Type
Experimental
Arm 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 )
Intervention Type
Procedure
Intervention Name(s)
Lumbar medial branch radiofrequency ablation neurotomy
Intervention Description
Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Intervention Type
Procedure
Intervention Name(s)
Lumbar medial branch cryo ablation neurotomy
Intervention Description
Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
Primary Outcome Measure Information:
Title
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
Description
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Time Frame
6 months follow-up
Title
Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
Description
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Time Frame
12 months follow-up
Title
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
Description
VAS 10 point measurement
Time Frame
6 months follow-up
Title
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m
Description
VAS 10 point measurement
Time Frame
12 months follow-up
Title
Oswestry disability index (ODI) 6m
Description
The ODI self-administered questionnaire measuring 0-100 scale
Time Frame
6 months follow-up
Title
Oswestry disability index (ODI) 12m
Description
The ODI self-administered questionnaire measuring 0-100 scale
Time Frame
12 months follow-up
Secondary Outcome Measure Information:
Title
Before procedure drug usage
Description
drug usage
Time Frame
before procedure
Title
Postprocedural drug usage
Description
drug usage
Time Frame
12 months follow-up
Title
Appearance and rate of complications related to procedure
Description
complications
Time Frame
12 months follow-up
Title
Dose of radiation exposure
Description
complications
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ladislav Kocan, MD PhD
Phone
+421557891110
Email
europainclinicsstudy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Rapcan, MD PhD FIPP
Email
rapcan@europainclinics.com
Facility Information:
Facility Name
EuroPainClinics
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rapcan Robert, MD FIPP
Phone
+421 948 602 510
Email
rapcan@europainclinics.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)

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