EuroPainClinicsStudy IX

Failed Back Surgery Syndrome Clinical Trial

— EPCS IX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686903
• Other study ID #: 03595/2020/OZ-30
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Europainclinics z.ú.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

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
• 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)
• 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)

Locations

Country	Name	City	State
Slovakia	EuroPainClinics	Bardejov

Sponsors (4)

Lead Sponsor	Collaborator
Europainclinics z.ú.	Brno University Hospital, Pavol Jozef Safarik University, Slovak Academy of Sciences

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m	VAS 10 point measurement	6 months follow-up
Primary	Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m	VAS 10 point measurement	12 months follow-up
Primary	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
Primary	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	Before procedure drug usage	drug usage	before procedure
Secondary	Postprocedural drug usage	drug usage	before procedure
Secondary	Radiation exposure	Dose of radiation exposure	12 months follow-up