Chronic Low Back Pain - Epiduroscopy Treatment | NCT03916666

Studies
Chronic Low Back Pain - Epiduroscopy Treatment

NCT03916666

Sponsor

Pavol Jozef Safarik University

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Chronic Low Back Pain

Interventions

Epiduroscopy

Countries

Czechia
Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2021Estimated

Primary Completion Date

Dec 11, 2021Estimated

Completion Date

Dec 21, 2021Estimated

First Submitted Date

Apr 8, 2019

First Submission Date that Met QC Criteria

Apr 12, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Name	Class
EPC Education s.r.o.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective analysis of patients with low back pain after epiduroscopic procedure

Detailed Description

Retrospective analysis of patients with low back pain after epiduroscopic procedure Retrospective analysis of ambulatory data and next phone survey

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Epiduroscopy	Procedure	Endoscopic intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of back pain after epiduroscopic procedure		1 year
Incidence of leg pain after epiduroscopic procedure		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients after epiduroscopy

Exclusion Criteria:

patients disagreement

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

After epiduroscopy, FBSS Y/N

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ladislav Kocan, MD PhD	Contact	00421907440250		lkocan@vusch.sk
Robert Rapcan, MD PhD	Contact	00421907440250		rapcan@europainclinics.sk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EuroPainClinics .z.ú	Recruiting	Prague	Smetanovo Nábřeží 327/14	110 00	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided