EuroPainClinics® Study V (Prospective Observational Study) (EPCSV)

Europainclinics z.ú.

Status: Completed

Conditions: Back Pain; Intervertebral Disc Herniation

Treatments: Procedure: Endoscopic disectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02742311

EK: 9N-2015

Details and patient eligibility

About

In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.

Enrollment: 500 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI

Exclusion criteria

• The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

transforaminal endoscopic discectomy

Active Comparator group

Treatment:

Procedure: Endoscopic disectomy

interlaminar endoscopic discectomy

Active Comparator group

Treatment:

Procedure: Endoscopic disectomy