EuroPainClinicsStudy IX ( EPCS IX )
CompletedNot applicableNCT07411950
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prospective Comparative Study of Epiduroscopic Adhesiolysis in Patients With Failed Back Surgery Syndrome and Patients Without Prior Lumbar Surgery
- Conditions
- Interventions
- Procedure: Epiduroscopic mechanical adhesiolysis
- Drug: Epidural pharmacologic therapy
- Sponsor
- EPC Education s.r.o.
- Collaborators
- Slovak Academy of Sciences; East Slovak Institute for Cardiovascular Diseases
- Start date
- 2021-01-01
- Primary completion
- 2025-05-31
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Slovakia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07411950