Back to resultsEuroPainClinics® Study V (Prospective Observational Study) (EPCSV)
Primary Purpose
Back Pain, Intervertebral Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Endoscopic disectomy
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility 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
Sites / Locations
- Europainclinics algesiology ambulance
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transforaminal endoscopic discectomy
interlaminar endoscopic discectomy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
2.Pain localization as assessed by note of radiating dermatome as neurologic examination
All acquired information will be noted in to the special anonymous protocol
3.Pain progress as assessed by global pain scale
All acquired information will be noted in to the special anonymous protocol
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
All acquired information will be noted in to the special anonymous protoco
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02742311
Brief Title
EuroPainClinics® Study V (Prospective Observational Study)
Acronym
EPCSV
Official Title
EuroPainClinics® Study V (Prospective Observational Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Europainclinics z.ú.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Intervertebral Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transforaminal endoscopic discectomy
Arm Type
Active Comparator
Arm Title
interlaminar endoscopic discectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic disectomy
Intervention Description
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 Measure Information:
Title
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol
Description
All acquired information will be noted in to the special anonymous protocol
Time Frame
3 years
Secondary Outcome Measure Information:
Title
2.Pain localization as assessed by note of radiating dermatome as neurologic examination
Description
All acquired information will be noted in to the special anonymous protocol
Time Frame
3 years
Title
3.Pain progress as assessed by global pain scale
Description
All acquired information will be noted in to the special anonymous protocol
Time Frame
3 years
Title
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
Description
All acquired information will be noted in to the special anonymous protoco
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav Burianek, MD MPH
Organizational Affiliation
Director
Official's Role
Study Chair
Facility Information:
Facility Name
Europainclinics algesiology ambulance
City
Bardejov
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EuroPainClinics® Study V (Prospective Observational Study)
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