EuroPainClinicsStudy X (EPCS X)

Europainclinics z.ú.

Status

Unknown

Conditions

Back Pain

Treatments

Other: Retrospective observation after 12 months after the spinal procedure

Other: Retrospective observation after 24 months after the spinal procedure

Other: Prospective evaluation of patients after 12 and 24 months after the spinal procedure

Study type

Observational

Funder types

Other

Identifiers

NCT04855682

4184/2021/ODDZ-11156

Details and patient eligibility

About

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

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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