CompletedNot Applicable

EuroPainClinicsStudy IX

Slovakia150 participantsStarted 2020-01-01

Plain-language summary

Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS

Who can participate

Age range

20 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: * patients aged between 20 and 80 * patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS \>=5) on lower extremities * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form Exclusion Criteria: * more than 2 lumbar laminectomies * patients without previous spine surgery * patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years * other patients viewed as inappropriate by the staff * disagreement with participation in the study

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 from baseline EuroQoL-5 dimension (EQ-5D) value 6m

Timeframe: 6 months follow-up

Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m

Timeframe: 12 months follow-up

Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m

Timeframe: 6 months follow-up

Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m

Timeframe: 12 months follow-up

Oswestry disability index (ODI) 6m

Timeframe: 6 months follow-up

Oswestry disability index (ODI) 12m

Timeframe: 12 months follow-up

Trial details

NCT IDNCT04686903

SponsorEPC Education s.r.o.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

View on ClinicalTrials.gov More Failed Back Surgery Syndrome trials

Who can participate

Age range

20 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.