EuroPainClinicsStudy IX

NCT04686903 | Completed DMC

• 1 other identifier: 03595/2020/OZ-30
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (6)

• 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

• 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

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

  VAS 10 point measurement

  6 months follow-up

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

  VAS 10 point measurement

  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.

  6 months follow-up

• 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 Outcomes (3)

• Before procedure drug usage

  before procedure

• Postprocedural drug usage

  before procedure

• Radiation exposure

  12 months follow-up

Study Arms (3)

Epiduroscopy

EXPERIMENTAL

Epiduroscopy in patients with FBSS

Procedure: Epiduroscopy treatment

Racz catheter epidural procedure

EXPERIMENTAL

Racz catheter epidural procedure in patients with FBSS

Procedure: Racz catheter epidural procedure

Caudal epidural block

EXPERIMENTAL

Caudal epidural block treatment of FBSS

Procedure: Caudal epidural block

Interventions

Epiduroscopy treatment PROCEDURE

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

Epiduroscopy

Racz catheter epidural procedure 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)

Racz catheter epidural procedure

Caudal epidural block PROCEDURE

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)

Caudal epidural block

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Europainclinics z.ú.: lead
• Brno University Hospital: collaborator
• Slovak Academy of Sciences: collaborator
• Pavol Jozef Safarik University: collaborator

Study Sites (1)

EuroPainClinics

Bardejov, 085 01, Slovakia

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Miroslav Burianek, MD MBA

  Europainclinics z.ú.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 29, 2020
• Study Start: January 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)