EuroPainClinics® Study V (Prospective Observational Study) (EPCSV)

December 30, 2021 updated by: Europainclinics z.ú.
In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bardejov, Slovakia
        • Europainclinics algesiology ambulance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI

Exclusion Criteria:

  • The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transforaminal endoscopic discectomy
Procedure: Endoscopic disectomy
Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.
Active Comparator: interlaminar endoscopic discectomy
Procedure: Endoscopic disectomy
Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol
Time Frame: 3 years
All acquired information will be noted in to the special anonymous protocol
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2.Pain localization as assessed by note of radiating dermatome as neurologic examination
Time Frame: 3 years
All acquired information will be noted in to the special anonymous protocol
3 years
3.Pain progress as assessed by global pain scale
Time Frame: 3 years
All acquired information will be noted in to the special anonymous protocol
3 years
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
Time Frame: 3 years
All acquired information will be noted in to the special anonymous protoco
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Europainclinics z.ú.

Investigators

  • Study Chair: Miroslav Burianek, MD MPH, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 10, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK: 9N-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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