EuroPainClinicsStudy IX

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

August 31, 2021

Study Completion Date

December 31, 2021

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)"

Trial Locations (1)

085 01

EuroPainClinics, Bardejov

All Listed Sponsors
collaborator

Brno University Hospital

OTHER

collaborator

Slovak Academy of Sciences

OTHER_GOV

collaborator

Pavol Jozef Safarik University

OTHER

lead

Europainclinics z.ú.

OTHER

NCT04686903 - EuroPainClinicsStudy IX | Biotech Hunter | Biotech Hunter