EuroPainClinicsStudy X
EPCS X
1 other identifier
observational
180
1 country
3
Brief Summary
Non-interventional, retrospective-prospective cohort study based on the collection of data and their evaluation after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedMay 26, 2021
May 1, 2021
9 months
April 18, 2021
May 22, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
Fat degeneration of muscles
Fat degeneration of musculus erector spinae and multifidus muscles evaluated by comparing the pre-operative current MRI of the lumbosacral spine using the 2-point Dixon Technique and Goutallier classification in each group
12 months after procedure
Fat degeneration of muscles
Fat degeneration of musculus erector spinae and multifidus muscles evaluated by comparing the pre-operative current MRI of the lumbosacral spine using the 2-point Dixon Technique and Goutallier classification in each group
24 months after procedure
Oswestry disability index (ODI)
ODI is based on a questionnaire, which includes 10 items, each one has 6 possible answers. Each item is rated from 0 to 5 and the sum of all answers is evaluated on a scale from 0-100, with higher scores meaning more serious symptoms.
12 months and 24 months after procedure
Oswestry disability index (ODI)
ODI is based on a questionnaire, which includes 10 items, each one has 6 possible answers. Each item is rated from 0 to 5 and the sum of all answers is evaluated on a scale from 0-100, with higher scores meaning more serious symptoms.
24 months after procedure
EQ-5D-5L
EQ-5D is a standardized questionnaire tool developed by the EuroQol group as a measure of the quality of life linked to health, that can be used in a wide spectrum of health conditions and their treatment. The system has 5 dimensions: mobility, being able to take care of oneself, every-day activities, pain/discomfort and anxiety/depression. Each system can be graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems. T Changes in the visual analogue scale (VAS) of lower limb pain evaluated on a scale of 0 to 10
12 months after procedure
EQ-5D-5L
EQ-5D is a standardized questionnaire tool developed by the EuroQol group as a measure of the quality of life linked to health, that can be used in a wide spectrum of health conditions and their treatment. The system has 5 dimensions: mobility, being able to take care of oneself, every-day activities, pain/discomfort and anxiety/depression. Each system can be graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems. T Changes in the visual analogue scale (VAS) of lower limb pain evaluated on a scale of 0 to 10
24 months after procedure
Secondary Outcomes (4)
Usage of painkillers before and after the procedures
12 months after procedure
Usage of painkillers before and after the procedures
24 months after procedure
Occurrence of early and late post-surgery complications
12 months after procedure
Occurrence of early and late post-surgery complications
24 months after procedure
Study Arms (3)
A
Endoscopic discectomy
B
Microdisectomy
C
Hemilaminectomy
Interventions
Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes
Eligibility Criteria
Patients after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.
You may qualify if:
- patient age 18-60 years
- first spinal surgery in the areas L1-S1
- signed informed consent for the participation in the study
You may not qualify if:
- patients with a history of other back problems (compression fracture, spondylitis, tumour)
- patients after repeated spinal surgeries
- patients with a systemic disease affecting the muscles elite athletes
- patients who disagree to participate in the study
- women with a positive pregnancy test or women planning on becoming pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Europainclinics z.ú.lead
- R-CLINIC s.r.o.collaborator
- Faculty Hospital Nitracollaborator
- Slovak Academy of Sciencescollaborator
- University Hospital Bratislavacollaborator
Study Sites (3)
R - Clinic s.r.o.
Bardejov, 04011, Slovakia
R - Clinic s.r.o.
Bardejov, 085 01, Slovakia
R - Clinic s.r.o.
Bardejov, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miroslav Burianek, MD MBA
clinical monitor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Manager
Study Record Dates
First Submitted
April 18, 2021
First Posted
April 22, 2021
Study Start
July 15, 2021
Primary Completion
April 15, 2022
Study Completion
April 15, 2024
Last Updated
May 26, 2021
Record last verified: 2021-05