NCT07411950

EuroPainClinicsStudy IX ( EPCS IX )

Prospective Comparative Study of Epiduroscopic Adhesiolysis in Patients With Failed Back Surgery Syndrome and Patients Without Prior Lumbar Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: EPC Education s.r.o. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This investigator-initiated prospective, multicenter, randomized, double-blind controlled study was conducted at certified interventional pain centers in Slovakia to evaluate the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with chronic lumbar radicular pain. The protocol was approved by regional ethics committees, and all participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles. Eligible participants were adults with chronic lumbosacral radicular pain persisting for more than six months despite conservative treatment. Patients were enrolled into two predefined clinical cohorts according to surgical history: (1) failed back surgery syndrome (FBSS), defined as persistent or recurrent radicular pain following lumbar spine surgery, and (2) surgery-naïve patients without prior lumbar surgery. Cohort allocation was performed prior to randomization, while all other eligibility criteria were identical across groups. Within each cohort, participants were randomized in a 1:1 ratio to undergo either epiduroscopic mechanical adhesiolysis alone or mechanical adhesiolysis combined with targeted epidural pharmacologic therapy. Randomization was computer-generated and stratified by study center. The study was double-blinded; patients and outcome assessors were unaware of treatment assignment, while the operating physician did not participate in follow-up evaluations. All procedures were performed via a sacral epidural approach under fluoroscopic guidance using a flexible epiduroscope. Mechanical adhesiolysis consisted of endoscopic dissection and saline irrigation to release epidural adhesions around symptomatic nerve roots. In the pharmacologic treatment groups, adhesiolysis was followed by epidural administration of methylprednisolone acetate (40 mg), hyaluronidase (1,500 IU), and hypertonic saline (10 mL). In the mechanical-only groups, isotonic saline was administered to maintain blinding. Procedural and perioperative management were standardized across centers. Clinical assessments were performed at baseline and at 6 months after the procedure. Outcomes included pain intensity measured by the Numeric Rating Scale (NRS), health-related quality of life assessed using EQ-VAS and EQ-5D-5L, functional status, analgesic consumption, and procedure-related adverse events. All evaluations were conducted by blinded assessors. Statistical analyses followed the intention-to-treat principle, and differences between groups and time points were analyzed using appropriate statistical methods.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-05-31
• Completion: 2025-11-30
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Slovakia