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 range18 Years – 80 Years

SexALL

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

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 range18 Years – 80 Years

SexALL

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