EuroPainClinics® Study V (Prospective Observational Study)

Back Pain Clinical Trial

— EPCSV  

Official title:

EuroPainClinics® Study V (Prospective Observational Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742311
• Other study ID #: EK: 9N-2015
• Status: Completed
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Europainclinics z.ú.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Hernia
• Intervertebral Disc Herniation

Intervention

Procedure:
• Endoscopic disectomy
Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.

Locations

Country	Name	City	State
Slovakia	Europainclinics algesiology ambulance	Bardejov

Sponsors (1)

Lead Sponsor	Collaborator
Europainclinics z.ú.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol	All acquired information will be noted in to the special anonymous protocol	3 years
Secondary	2.Pain localization as assessed by note of radiating dermatome as neurologic examination	All acquired information will be noted in to the special anonymous protocol	3 years
Secondary	3.Pain progress as assessed by global pain scale	All acquired information will be noted in to the special anonymous protocol	3 years
Secondary	4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids	All acquired information will be noted in to the special anonymous protoco	3 years