EuroPainClinics® Study V (Prospective Observational Study)
EPCSV
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedStudy Start
First participant enrolled
December 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 13, 2022
December 1, 2021
Same day
April 10, 2016
December 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol
All acquired information will be noted in to the special anonymous protocol
3 years
Secondary Outcomes (3)
2.Pain localization as assessed by note of radiating dermatome as neurologic examination
3 years
3.Pain progress as assessed by global pain scale
3 years
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
3 years
Study Arms (2)
transforaminal endoscopic discectomy
ACTIVE COMPARATORinterlaminar endoscopic discectomy
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Europainclinics algesiology ambulance
Bardejov, Slovakia
Related Publications (1)
Rapcan R, Kocan L, Witkovsky V, Rapcanova S, Mlaka J, Tirpak R, Burianek M, Kocanova H, Vaskova J, Gajdos M. Endoscopic discectomy of the herniated intervertebral disc and changes in quality-of-life EQ-5D-5L analysis. Medicine (Baltimore). 2023 Jun 30;102(26):e34188. doi: 10.1097/MD.0000000000034188.
PMID: 37390280DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miroslav Burianek, MD MPH
Director
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2016
First Posted
April 19, 2016
Study Start
December 31, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
January 13, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share