EuroPainClinics® Study V (Prospective Observational Study)

NCT ID: NCT02742311

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Back Pain Intervertebral Disc Herniation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transforaminal endoscopic discectomy

Group Type ACTIVE_COMPARATOR

Endoscopic disectomy

Intervention Type PROCEDURE

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.

interlaminar endoscopic discectomy

Group Type ACTIVE_COMPARATOR

Endoscopic disectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Europainclinics z.ú.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miroslav Burianek, MD MPH

Role: STUDY_CHAIR

Director

Locations

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Europainclinics algesiology ambulance

Bardejov, , Slovakia

Site Status

Countries

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Slovakia

References

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Rapcan R, Kocan L, Witkovsky V, Rapcanova S, Mlaka J, Tirpak R, Burianek M, Kocanova H, Vaskova J, Gajdos M. Endoscopic discectomy of the herniated intervertebral disc and changes in quality-of-life EQ-5D-5L analysis. Medicine (Baltimore). 2023 Jun 30;102(26):e34188. doi: 10.1097/MD.0000000000034188.

Reference Type DERIVED
PMID: 37390280 (View on PubMed)

Other Identifiers

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EK: 9N-2015

Identifier Type: -

Identifier Source: org_study_id

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