EuroPainClinicsStudy X

• Conditions: Back Pain
• Interventions: 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

• Registration Number: NCT04855682
• Lead Sponsor: Europainclinics z.ú.

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.

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 Timeline

• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-22
• Last Update Posted: 2021-05-26
• Study Start: 2021-07-15
• Primary Completion: 2022-04-15
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Retrospective observation after 12 months after the spinal procedure	Endoscopic discectomy
B	Retrospective observation after 12 months after the spinal procedure	Microdisectomy
C	Retrospective observation after 24 months after the spinal procedure	Hemilaminectomy
C	Retrospective observation after 12 months after the spinal procedure	Hemilaminectomy
C	Prospective evaluation of patients after 12 and 24 months after the spinal procedure	Hemilaminectomy
A	Retrospective observation after 24 months after the spinal procedure	Endoscopic discectomy
B	Prospective evaluation of patients after 12 and 24 months after the spinal procedure	Microdisectomy
A	Prospective evaluation of patients after 12 and 24 months after the spinal procedure	Endoscopic discectomy
B	Retrospective observation after 24 months after the spinal procedure	Microdisectomy

Primary Outcome Measures

Name	Time	Method
Fat degeneration of muscles	24 months after procedure	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
Oswestry disability index (ODI)	24 months after procedure	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.
EQ-5D-5L	24 months after procedure	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

Secondary Outcome Measures

Name	Time	Method
Occurrence of early and late post-surgery complications	24 months after procedure
Usage of painkillers before and after the procedures	24 months after procedure

Trial Locations

Locations (1)

R - Clinic s.r.o.; 🇸🇰 Bardejov, Slovakia