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EuroPainClinicsStudy IX

NCT04686903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-01-03

No results posted yet for this study

Summary

Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS

Conditions

  • Failed Back Surgery Syndrome

Interventions

PROCEDURE

Epiduroscopy treatment

Device Epiduroscop, procedure mecahnical lysis, laser, radiofrequency + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) Follow-up: before procedure, 6 months and 12 months after procedure

PROCEDURE

Racz catheter epidural procedure

Device Racz catheter, two procedures during clinical trial observation * First procedure after enrolment into the study mechanical lysis and drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) * Second procedure after 6 months mechanical lysis + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)

PROCEDURE

Caudal epidural block

Technique Caudal epidural block Three procedures during clinical trial observation : * First procedure after enrolment into the study drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) * Second procedure after 4 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg) * Third procedure after 8 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg)

Sponsors & Collaborators

  • Brno University Hospital

    collaborator OTHER

  • Slovak Academy of Sciences

    collaborator OTHER_GOV

  • Pavol Jozef Safarik University

    collaborator OTHER

  • Europainclinics z.ú.

    lead OTHER

Principal Investigators

  • Miroslav Burianek, MD MBA · Europainclinics z.ú.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-08-31
Completion
2021-12-31

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04686903 on ClinicalTrials.gov