EuroPainClinicsStudy X

Study Overview
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Brief Summary
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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
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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.

Official Title
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EuroPainClinicsStudy X (Minimally Invasive Spinal Surgical Approaches)

Conditions
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Back Pain

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Endoscopic discectomy | Other: Retrospective observation after 24 months after the spinal procedure<br>* 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<br>* Other names: MRI description;Other: Retrospective observation after 12 months after the spinal procedure<br>* 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<br>* Other names: MRI description;Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure<br>* Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes<br>* Other names: MRI description;|
| B<br>Microdisectomy | Other: Retrospective observation after 24 months after the spinal procedure<br>* 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<br>* Other names: MRI description;Other: Retrospective observation after 12 months after the spinal procedure<br>* 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<br>* Other names: MRI description;Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure<br>* Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes<br>* Other names: MRI description;|
| C<br>Hemilaminectomy | Other: Retrospective observation after 24 months after the spinal procedure<br>* 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<br>* Other names: MRI description;Other: Retrospective observation after 12 months after the spinal procedure<br>* 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<br>* Other names: MRI description;Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure<br>* Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes<br>* Other names: MRI description;|

What is the study measuring?
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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 | Measure Description | 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 |