EuroPainClinicsStudy IX (EPCS IX)

Prospective Comparison Between Epiduroscopy Procedure, Racz Catheter Procedure and Caudal Epidural Block in Patients With FBSS

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

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Procedure: Epiduroscopy treatment; Procedure: Racz catheter epidural procedure; Procedure: Caudal epidural block

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bardejov, Slovakia, 085 01
    • Europainclinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epiduroscopy; Epiduroscopy in patients with FBSS	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
Experimental: Racz catheter epidural procedure; Racz catheter epidural procedure in patients with FBSS	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)
Experimental: Caudal epidural block; Caudal epidural block treatment of FBSS	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m	VAS 10 point measurement	6 months follow-up
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m	VAS 10 point measurement	12 months follow-up
Oswestry disability index (ODI) 6m	he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.	6 months follow-up
Oswestry disability index (ODI) 12m	he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms.	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Before procedure drug usage	drug usage	before procedure
Postprocedural drug usage	drug usage	before procedure
Radiation exposure	Dose of radiation exposure	12 months follow-up

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Collaborators: Brno University Hospital; Pavol Jozef Safarik University; Slovak Academy of Sciences
• Investigators: Study Chair: Miroslav Burianek, MD MBA, Europainclinics z.ú.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: 03595/2020/OZ-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: encrypted database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No