EuroPainClinicsStudy IX

Europainclinics z.ú.150 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Failed Back Surgery Syndrome

Interventions

Epiduroscopy treatmentPROCEDURE

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 procedurePROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

EuroPainClinics

Bardejov, Slovakia

Outcomes

Primary Outcomes

Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Time frame: 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

Time frame: 12 months follow-up

Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m

VAS 10 point measurement

Time frame: 6 months follow-up

Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m

VAS 10 point measurement

Time frame: 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.

Time frame: 6 months follow-up

Oswestry disability index (ODI) 12m

Time frame: 12 months follow-up

Secondary Outcomes

Before procedure drug usage

Data from ClinicalTrials.gov

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