EuroPainClinicsStudy IX (EPCS IX)

Europainclinics z.ú.

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Procedure: Racz catheter epidural procedure; Procedure: Epiduroscopy treatment; Procedure: Caudal epidural block

Study type: Interventional

Funder types: Other

Identifiers

NCT04686903

03595/2020/OZ-30

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Epiduroscopy

Experimental group

Description:

Epiduroscopy in patients with FBSS

Treatment:

Procedure: Epiduroscopy treatment

Racz catheter epidural procedure

Experimental group

Description:

Racz catheter epidural procedure in patients with FBSS

Treatment:

Procedure: Racz catheter epidural procedure

Caudal epidural block

Experimental group

Description:

Caudal epidural block treatment of FBSS

Treatment:

Procedure: Caudal epidural block