Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

EuroPainClinicsStudy IX (EPCS IX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686903
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : January 3, 2022
Sponsor:
Collaborators:
Brno University Hospital
Slovak Academy of Sciences
Pavol Jozef Safarik University
Information provided by (Responsible Party):
Europainclinics z.ú.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Procedure: Epiduroscopy treatment Procedure: Racz catheter epidural procedure Procedure: Caudal epidural block Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Comparison Between Epiduroscopy Procedure, Racz Catheter Procedure and Caudal Epidural Block in Patients With FBSS
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : December 31, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Epiduroscopy
Epiduroscopy in patients with FBSS
 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
Experimental: Racz catheter epidural procedure
Racz catheter epidural procedure in patients with FBSS
 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)
Experimental: Caudal epidural block
Caudal epidural block treatment of FBSS
 Procedure: 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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m [ Time Frame: 6 months follow-up ]
    EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

  2. Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m [ Time Frame: 12 months follow-up ]
    EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

  3. Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m [ Time Frame: 6 months follow-up ]
    VAS 10 point measurement

  4. Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m [ Time Frame: 12 months follow-up ]
    VAS 10 point measurement

  5. Oswestry disability index (ODI) 6m [ Time Frame: 6 months follow-up ]
    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. Oswestry disability index (ODI) 12m [ Time Frame: 12 months follow-up ]
    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.


Secondary Outcome Measures :
  1. Before procedure drug usage [ Time Frame: before procedure ]
    drug usage

  2. Postprocedural drug usage [ Time Frame: before procedure ]
    drug usage

  3. Radiation exposure [ Time Frame: 12 months follow-up ]
    Dose of radiation exposure


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686903


Locations
Layout table for location information
Slovakia
EuroPainClinics
Bardejov, Slovakia, 085 01
Sponsors and Collaborators
Europainclinics z.ú.
Brno University Hospital
Slovak Academy of Sciences
Pavol Jozef Safarik University
Investigators
Layout table for investigator information
Study Chair: Miroslav Burianek, MD MBA Europainclinics z.ú.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Europainclinics z.ú.
ClinicalTrials.gov Identifier: NCT04686903    
Other Study ID Numbers: 03595/2020/OZ-30
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: encrypted database

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Failed Back Surgery Syndrome
Postoperative Complications
Pathologic Processes
 Back Pain
Pain
Neurologic Manifestations