NCT03916666

Brief Summary

Retrospective analysis of patients with low back pain after epiduroscopic procedure

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 11, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

Same day

First QC Date

April 8, 2019

Last Update Submit

June 9, 2020

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • Incidence of back pain after epiduroscopic procedure

    1 year

  • Incidence of leg pain after epiduroscopic procedure

    1 year

Interventions

EpiduroscopyPROCEDURE

Endoscopic intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After epiduroscopy, FBSS Y/N

You may qualify if:

  • all patients after epiduroscopy

You may not qualify if:

  • patients disagreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EuroPainClinics .z.ú

Prague, Smetanovo Nábřeží 327/14, 110 00, Czechia

RECRUITING

East Slovak Institute for Cardiovascular Diseases

Košice, 04011, Slovakia

RECRUITING

Central Study Contacts

Ladislav Kocan, MD PhD

CONTACT

00421907440250lkocan@vusch.sk

Robert Rapcan, MD PhD

CONTACT

00421907440250rapcan@europainclinics.sk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 16, 2019

Study Start

December 11, 2021

Primary Completion

December 11, 2021

Study Completion

December 21, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)SL(1)