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 range20 Years – 80 Years

SexALL

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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

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