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EuroPainClinicsStudy IX ( EPCS IX )

NCT07411950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-02-17

No results posted yet for this study

Summary

This prospective investigator-initiated study compares the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with failed back surgery syndrome (FBSS) and in patients with lumbar radicular pain without prior lumbar surgery. Epiduroscopy allows direct visualization of the epidural space with targeted mechanical adhesiolysis and optional epidural pharmacologic treatment. The primary objective is to evaluate pain relief and functional improvement following the procedure. Secondary outcomes include disability scores, quality of life, and procedure-related complications. The study aims to determine whether prior lumbar surgery influences clinical outcomes after epiduroscopic treatment.

Conditions

  • Failed Back Surgery Syndrome
  • Lumbar Radiculopathy
  • Chronic Low Back Pain
  • Epidural Fibrosis

Interventions

PROCEDURE

Epiduroscopic mechanical adhesiolysis

Percutaneous epiduroscopy performed via a sacral approach under fluoroscopic guidance using a flexible epiduroscope. Mechanical dissection and saline irrigation were used to release epidural fibrotic adhesions and decompress symptomatic nerve roots.

DRUG

Epidural pharmacologic therapy

Targeted epidural administration of methylprednisolone acetate (40 mg), hyaluronidase (1,500 IU), and hypertonic saline (10 mL) delivered under fluoroscopic or endoscopic guidance following mechanical adhesiolysis.

Sponsors & Collaborators

  • Slovak Academy of Sciences

    collaborator OTHER_GOV

  • East Slovak Institute for Cardiovascular Diseases

    collaborator OTHER

  • Europainclinics z.ú.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-05-31
Completion
2025-11-30

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07411950 on ClinicalTrials.gov