Clinical trial NCT04686903: EuroPainClinicsStudy IX
Official title: Prospective Comparison Between Epiduroscopy Procedure, Racz Catheter Procedure and Caudal Epidural Block in Patients With FBSS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: Slovak Academy of Sciences
name: Pavol Jozef Safarik University
First posted: 2020-12-29
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 paralel groups: Group A Epiduroscopy in patients with FBSS (50 patients) Group B Racz catheter epidural procedure in patients with FBSS (50 patients) Group C Caudal epidural block in patients with FBSS (50 patients)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
timeFrame: 6 months follow-up
measure: Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
timeFrame: 12 months follow-up
measure: Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
timeFrame: 6 months follow-up
measure: Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m
timeFrame: 12 months follow-up
measure: Oswestry disability index (ODI) 6m
timeFrame: 6 months follow-up
measure: Oswestry disability index (ODI) 12m
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Before procedure drug usage
timeFrame: before procedure
measure: Postprocedural drug usage
timeFrame: before procedure
measure: Radiation exposure
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Bardejov
country: Slovakia
facility: EuroPainClinics
Study officials:
affiliation: Europainclinics z.ú.
name: Miroslav Burianek, MD MBA
role: STUDY_CHAIR
References: