EuroPainClinics® Study V (Prospective Observational Study)

Not Applicable

Completed

• Conditions: Back Pain; Intervertebral Disc Herniation
• Interventions: Procedure: Endoscopic disectomy

• Registration Number: NCT02742311
• Lead Sponsor: Europainclinics z.ú.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-10
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Study Start: 2021-12-31
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transforaminal endoscopic discectomy	Endoscopic disectomy	-
interlaminar endoscopic discectomy	Endoscopic disectomy	-

Primary Outcome Measures

Name	Time	Method
1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol	3 years	All acquired information will be noted in to the special anonymous protocol

Secondary Outcome Measures

Name	Time	Method
4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids	3 years	All acquired information will be noted in to the special anonymous protoco
3.Pain progress as assessed by global pain scale	3 years	All acquired information will be noted in to the special anonymous protocol
2.Pain localization as assessed by note of radiating dermatome as neurologic examination	3 years	All acquired information will be noted in to the special anonymous protocol

Trial Locations

Locations (1)

Europainclinics algesiology ambulance; 🇸🇰 Bardejov, Slovakia