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Completed

NCT Number: NCT02742311

EuroPainClinics® Study V (Prospective Observational Study)

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.

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Key information

Conditions

Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Intervertebral Disc Herniation Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Europainclinics algesiology ambulance

Bardejov, Slovakia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic disectomy

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.

Primary outcomes

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

    Time frame: 3 years

    All acquired information will be noted in to the special anonymous protocol

Secondary outcomes

  1. 2.Pain localization as assessed by note of radiating dermatome as neurologic examination

    Time frame: 3 years

    All acquired information will be noted in to the special anonymous protocol

  2. 3.Pain progress as assessed by global pain scale

    Time frame: 3 years

    All acquired information will be noted in to the special anonymous protocol

  3. 4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids

    Time frame: 3 years

    All acquired information will be noted in to the special anonymous protoco

Sponsors and collaborators

Lead sponsor

EPC Education s.r.o.

Other

Registry information

Acronym: EPCSV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2016
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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