EuroPainClinicsStudy X (EPCS X)

EuroPainClinicsStudy X (Minimally Invasive Spinal Surgical Approaches)

Non-interventional, retrospective-prospective cohort study based on the collection of data and their evaluation after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.

Study Overview

• Status: Recruiting
• Conditions: Back Pain
• Intervention / Treatment: Other: Retrospective observation after 24 months after the spinal procedure; Other: Retrospective observation after 12 months after the spinal procedure; Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure

Detailed Description

The aim of this clinical study is to compare the benefits and complications after minimally invasive spinal procedures in patients with acute lumbosacral radicular syndrome caused by a herniated disc compressing the spinal neural structures.

The study only works with patient data provided by the outpatient clinic for research analysis in the EPCS IV clinical study. All patient data are encrypted during collection and evaluation during the study, and stored in an encrypted database. The data will be evaluated by an independent institution - The Institute of Measurement of the Slovak Academy of Sciences.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Ladislav Kocan, MD PhD; Phone Number: +421557891100; Email: europainclinicsstudy@gmail.com
• Study Contact Backup: Name: Robert Rapcan, MD PhD FIPP; Email: rapcan@europainclinics.com

Study Locations

• Slovakia
  • Bardejov, Slovakia, 04011
    • Recruiting
    • R - Clinic s.r.o.
    • Contact: Ladislav Kočan, MD PhD
  • Bardejov, Slovakia, 085 01
    • Not yet recruiting
    • R - Clinic s.r.o.
    • Contact: Rapcan Robert, MD FIPP; Phone Number: +421 948 602 510; Email: rapcan@europainclinics.com
  • Bardejov, Slovakia
    • Recruiting
    • R - Clinic s.r.o.
    • Contact: Robert Rapčan, MD FIPP
    • Contact: Miroslav Burianek, MD MBA
    • Principal Investigator: Ladislav Kočan, MD PhD
    • Sub-Investigator: Viktor Witkovský, Doc. RNDr. CSc.
    • Sub-Investigator: Miroslav Gajdoš, Doc. MUDr., PhD
    • Sub-Investigator: René Hako, Mgr. MUDr. PhD., MHA, MPH
    • Sub-Investigator: Kamil Koleják, MUDr.PhD. MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.

Description

Inclusion Criteria:

• patient age 18-60 years
• first spinal surgery in the areas L1-S1
• signed informed consent for the participation in the study

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; Endoscopic discectomy	Other: Retrospective observation after 24 months after the spinal procedure; 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; Other Names: Quality of life; MRI description; Other: Retrospective observation after 12 months after the spinal procedure; 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; Other Names: Quality of life; MRI description; Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure; Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes; Other Names: Quality of life; MRI description
B; Microdisectomy	Other: Retrospective observation after 24 months after the spinal procedure; 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; Other Names: Quality of life; MRI description; Other: Retrospective observation after 12 months after the spinal procedure; 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; Other Names: Quality of life; MRI description; Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure; Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes; Other Names: Quality of life; MRI description
C; Hemilaminectomy	Other: Retrospective observation after 24 months after the spinal procedure; 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; Other Names: Quality of life; MRI description; Other: Retrospective observation after 12 months after the spinal procedure; 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; Other Names: Quality of life; MRI description; Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure; Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes; Other Names: Quality of life; MRI description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Collaborators: University Hospital Bratislava; Slovak Academy of Sciences; R-CLINIC s.r.o.; Faculty Hospital Nitra
• Investigators: Study Chair: Miroslav Burianek, MD MBA, clinical monitor

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2021
• Primary Completion (Anticipated): April 15, 2022
• Study Completion (Anticipated): April 15, 2024

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 22, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 4184/2021/ODDZ-11156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No