Status:

COMPLETED

Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis

Lead Sponsor:

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Conditions:

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Eligibility:

All Genders

50-85 years

Phase:

NA

Brief Summary

It will be done a prospective Study involving 38 patients with lumbar stenosis. A magnetic resonance (MR) imaging study and a electromyographic study will be done previously and 3 months after the epi...

Detailed Description

The investigators perform the Interventional Endoscopic Spinal Surgical (IESS) ,with the different instruments mentioned above. The Resaflex wich use Quantum Molecular Resonance, through combination o...

Eligibility Criteria

Inclusion

  • Patient with indication for epiduroscopy in the usual clinical practice
  • Neurogenic claudication
  • Lumbar pain for more than 6 months
  • Numerical rating scale \>6
  • No response with medical treatment
  • No response with other interventional treatment: epidurolysis

Exclusion

  • Psychiatric disorders
  • Opioid addiction
  • Acute organic disease
  • Severe chronic organic disease
  • Vasculo-cerebral disease
  • Coagulation alterations
  • Ofthalmologic disease
  • Allergic
  • Infections
  • Impossibility to understand the procedure

Key Trial Info

Start Date :

October 15 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 15 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03863067

Start Date

October 15 2018

End Date

October 15 2022

Last Update

March 6 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain, 28040