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Trial record 21 of 1645 for:    Slovakia

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

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ClinicalTrials.gov Identifier: NCT02742311
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Europainclinics z.ú.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Back Pain Intervertebral Disc Herniation Procedure: Endoscopic disectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EuroPainClinics® Study V (Prospective Observational Study)
Study Start Date : January 2016
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Endoscopy

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742311


Contacts
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Contact: Ladislav Kočan, MD PhD europainclinicsstudy@gmail.com
Contact: Robert Rapčan, MF FIPP rorapcan007@gmail.com

Locations
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Slovakia
Europainclinics algesiology ambulance Recruiting
Bardejov, Slovakia
Contact: Robert Rapčan         
Sponsors and Collaborators
Europainclinics z.ú.
Investigators
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Study Chair: Miroslav Burianek, MD MPH director

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Responsible Party: Europainclinics z.ú.
ClinicalTrials.gov Identifier: NCT02742311     History of Changes
Other Study ID Numbers: EK: 9N-2015
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms