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EuroPainClinics® Study II (Prospective Trial)

NCT02459392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-01-03

No results posted yet for this study

Summary

In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be examined in (approximately 300) adult patients with low back pain pain caused by failed back surgery syndrome (FBSS).

Conditions

  • Lumbar Spinal Stenosis

Interventions

OTHER

Epiduroscopy

Epiduroscopy has two main uses in the pain clinic: Releasing epidural adhesions for the relief of chronic sciatica. Adhesions can form around the lower lumbar nerve roots after decompressive surgery for disc disease or after a bad bout of inflammatory sciatica in the absence of surgery. Epidural adhesions can usually be identified on an enhanced magnetic resonance scan using intravenous gadolinium. They also cause uneven spread of X-ray contrast when performing an epidurogram. Injecting mixtures of local anesthetic and depot steroid around inflamed nerve roots when epidural injections / nerve root blocks have been unsuccessful. The presence of adhesions can prevent epidurally injected drugs from reaching the inflamed nerve roots.

DRUG

Hyaluronic Acid

Drug administration

DRUG

DepoMedrol

Drug administration

Sponsors & Collaborators

  • Europainclinics z.ú.

    lead OTHER

Principal Investigators

  • Juraj Mláka, MD PhD · R-Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459392 on ClinicalTrials.gov