EuroPainClinicsStudy IX

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Procedure: Epiduroscopy treatment; Procedure: Racz catheter epidural procedure; Procedure: Caudal epidural block

• Registration Number: NCT04686903
• Lead Sponsor: Europainclinics z.ú.

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Primary Completion: 2021-08-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Study Completion: 2021-12-31
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epiduroscopy	Epiduroscopy treatment	Epiduroscopy in patients with FBSS
Racz catheter epidural procedure	Racz catheter epidural procedure	Racz catheter epidural procedure in patients with FBSS
Caudal epidural block	Caudal epidural block	Caudal epidural block treatment of FBSS

Primary Outcome Measures

Name	Time	Method
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m	6 months follow-up	EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m	12 months follow-up	EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m	12 months follow-up	VAS 10 point measurement
Oswestry disability index (ODI) 12m	12 months follow-up	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.
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m	6 months follow-up	VAS 10 point measurement
Oswestry disability index (ODI) 6m	6 months follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Postprocedural drug usage	before procedure	drug usage
Radiation exposure	12 months follow-up	Dose of radiation exposure
Before procedure drug usage	before procedure	drug usage

Trial Locations

Locations (1)

EuroPainClinics; 🇸🇰 Bardejov, Slovakia