EuroPainClinicsStudy X

Back Pain Clinical Trial

— EPCS X  

Official title:

EuroPainClinicsStudy X (Minimally Invasive Spinal Surgical Approaches)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855682
• Other study ID #: 4184/2021/ODDZ-11156
• Status: Recruiting
• Start date: July 15, 2021
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2021
• Source: Europainclinics z.ú.
• Contact: Ladislav Kocan, MD PhD
• Phone: +421557891100
• Email: europainclinicsstudy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Slovakia	R - Clinic s.r.o.	Bardejov
Slovakia	R - Clinic s.r.o.	Bardejov
Slovakia	R - Clinic s.r.o.	Bardejov

Sponsors (5)

Lead Sponsor	Collaborator
Europainclinics z.ú.	Faculty Hospital Nitra, R-CLINIC s.r.o., Slovak Academy of Sciences, University Hospital Bratislava

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Usage of painkillers before and after the procedures		12 months after procedure
Secondary	Usage of painkillers before and after the procedures		24 months after procedure
Secondary	Occurrence of early and late post-surgery complications		12 months after procedure
Secondary	Occurrence of early and late post-surgery complications		24 months after procedure