Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07411950
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EuroPainClinicsStudy IX ( EPCS IX )
Sponsor:
EPC Education s.r.o.
Organization:
Study Overview
Official Title:
Prospective Comparative Study of Epiduroscopic Adhesiolysis in Patients With Failed Back Surgery Syndrome and Patients Without Prior Lumbar Surgery
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPCS IX
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: