CompletedNot Applicable

EuroPainClinicsStudy IX ( EPCS IX )

Slovakia141 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

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

Timeframe: 6 months

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

Timeframe: 6 months

Change in disability measured by Oswestry Disability Index (ODI)

Timeframe: 6 months

Trial details

NCT IDNCT07411950

SponsorEPC Education s.r.o.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Failed Back Surgery Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 6 months

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

Timeframe: 6 months

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

Timeframe: 6 months

Change in disability measured by Oswestry Disability Index (ODI)

Timeframe: 6 months