EuroPainClinicsStudy IX ( EPCS IX )

NCT07411950 | Completed DMC

• 1 other identifier: EK 03595/2020/OZ-30
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Epiduroscopy; Epiduroscopic adhesiolysis; Percutaneous epidural neurolysis; Mechanical adhesiolysis; Chronic radicular pain; Failed back surgery syndrome

Outcome Measures

Primary Outcomes (4)

• Change in health-related quality of life measured by EQ-5D-5L index value

  Change from baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) index score. Higher scores indicate better health status.

  6 months

• Change in leg pain intensity measured by Numeric Rating Scale (NRS)

  Change from baseline in leg pain intensity measured on an 11-point scale.

  6 months

• Change in back pain intensity measured by Numeric Rating Scale (NRS)

  Change from baseline in back pain intensity measured on an 11-point scale (0 = no pain, 10 = worst imaginable pain).

  6 months

• Change in disability measured by Oswestry Disability Index (ODI)

  Change from baseline in functional disability assessed using the Oswestry Disability Index (0-100%), with higher scores indicating greater disability.

  6 months

Study Arms (4)

FBSS - Mechanical Adhesiolysis

EXPERIMENTAL

Participants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis only.

Procedure: Epiduroscopic mechanical adhesiolysis

FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy

EXPERIMENTAL

Participants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural administration of methylprednisolone, hyaluronidase, and hypertonic saline.

Procedure: Epiduroscopic mechanical adhesiolysis; Drug: Epidural pharmacologic therapy

Surgery-Naïve - Mechanical Adhesiolysis

EXPERIMENTAL

Participants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis only.

Procedure: Epiduroscopic mechanical adhesiolysis

Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy

EXPERIMENTAL

Participants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural pharmacologic therapy.

Procedure: Epiduroscopic mechanical adhesiolysis; Drug: Epidural pharmacologic therapy

Interventions

Epiduroscopic mechanical adhesiolysis PROCEDURE

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.

FBSS - Mechanical Adhesiolysis; FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy; Surgery-Naïve - Mechanical Adhesiolysis; Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy

Epidural pharmacologic therapy DRUG

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.

FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy; Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy

Eligibility Criteria

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

You may qualify if:

• Age 20-80 years
• Chronic lumbosacral radicular pain persisting ≥ 6 months despite conservative treatment
• Failed back surgery syndrome (FBSS) with history of 1-2 prior lumbar laminectomies or surgery-naïve patients without prior lumbar surgery
• Lower extremity radicular pain with baseline pain intensity ≥ 5 on a 0-10 Numeric Rating Scale
• Ability to understand the study procedures and provide written informed consent

You may not qualify if:

• More than two prior lumbar spine surgeries
• Significant spinal pathology other than degenerative disease (e.g., fracture, tumor, infection, inflammatory spondylitis)
• Progressive neurological deficit
• Pregnancy or planned pregnancy during the study period
• Severe systemic illness or contraindication to epidural intervention
• Known allergy to study medications (steroids, hyaluronidase, or saline)
• Inability to complete follow-up assessments
• Any condition judged by investigators to make participation unsafe

Sponsors & Collaborators

• EPC Education s.r.o.: lead
• Slovak Academy of Sciences: collaborator
• East Slovak Institute for Cardiovascular Diseases: collaborator

Study Sites (1)

University of Pavol JoSef Safarik

Košice, 04011, Slovakia

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Radiculopathy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to treatment allocation. Mechanical-only groups received epidural isotonic saline to maintain blinding. The interventional physician performing the procedure was aware of allocation but was not involved in follow-up assessments or outcome evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Intensive Care

Model Details: Participants were first allocated to predefined clinical cohorts according to prior lumbar surgery status (failed back surgery syndrome or surgery-naïve). Within each cohort, patients were randomized in a 1:1 ratio to receive either mechanical epiduroscopic adhesiolysis alone or mechanical adhesiolysis combined with epidural pharmacologic therapy. All groups were treated and followed in parallel.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: January 1, 2021
• Primary Completion: May 31, 2025
• Study Completion: November 30, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)