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Completed

NCT Number: NCT04686903

EuroPainClinicsStudy IX

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

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EuroPainClinics

Bardejov, 085 01, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

EPC Education s.r.o.

Other

Collaborators

  • Brno University Hospital
  • Pavol Jozef Safarik University
  • Slovak Academy of Sciences

Registry information

Official study title

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

Acronym: EPCS IX

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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