EuroPainClinicsStudy IX

NCT ID: NCT04686903

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-12-31

Brief Summary

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

Detailed Description

I. Epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. Moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as "virgin back". Epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point.

II. The Racz catheter procedure is based on epidural neurolysis. It is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. This state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. Mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. This technique is performed under fluoroscopy imaging. Suitable epidurogram and skiascopy confirm appropriate catheter position during procedure.

III. The caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. Fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.

Conditions

Failed Back Surgery Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epiduroscopy

Epiduroscopy in patients with FBSS

Group Type: EXPERIMENTAL

Epiduroscopy treatment

Intervention Type: PROCEDURE

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

Racz catheter epidural procedure

Racz catheter epidural procedure in patients with FBSS

Group Type: EXPERIMENTAL

Racz catheter epidural procedure

Intervention Type: 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)

Caudal epidural block

Caudal epidural block treatment of FBSS

Group Type: EXPERIMENTAL

Caudal epidural block

Intervention Type: PROCEDURE

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)

Interventions

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

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients aged between 20 and 80
• patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS >=5) on lower extremities
• 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

• more than 2 lumbar laminectomies
• patients without previous spine surgery
• patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
• women with a positive 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: collaborator

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Pavol Jozef Safarik University

OTHER

Sponsor Role: collaborator

Europainclinics z.ú.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miroslav Burianek, MD MBA

Role: STUDY_CHAIR

Europainclinics z.ú.

Locations

EuroPainClinics

Bardejov, , Slovakia

Countries

Slovakia

Other Identifiers

03595/2020/OZ-30

Identifier Type: -

Identifier Source: org_study_id