CompletedNot Applicable

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

Spain40 participantsStarted 2018-10-15

Plain-language 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 epiduroscopy to confirm radiologic or neurophysiological changes. During the technic it will be used different instruments, an endoscope developed for its use in the epidural space (Resascope), a Fogarty balloon (Resaloon) to dilate the space near the epidural recess where it will be try to decrease the ligamentum flavum using the Resaflex, an instrument with Quantum Molecular Resonance for tissue coablation, in order to get less symptomatic lumbar stenosis. The investigators will compare qualitative and quantitative variables at baseline and 1, 3, 6, ant 12 months after the epiduroscopy.

Who can participate

Age range50 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Quantitative measurements in lumbar magnetic resonance imaging

Timeframe: Baseline

Quantitative measurements in lumbar magnetic resonance imaging

Timeframe: Three months after the technic

Qualitative changes in lumbar magnetic resonance imaging

Timeframe: Baseline

Qualitative changes in lumbar magnetic resonance imaging

Timeframe: three months after the technic

Numerical rating scale

Timeframe: Baseline

Numerical rating scale

Timeframe: 1 month after the technic

Numerical rating scale

Timeframe: 3 months after the technic

Numerical rating scale

Timeframe: 6 months after the technic

Trial details

NCT IDNCT03863067

SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-15

View on ClinicalTrials.gov More Spinal Stenosis, Lumbar Region, With Neurogenic Claudication trials

Plain-language summary

Who can participate

Age range50 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Quantitative measurements in lumbar magnetic resonance imaging

Timeframe: Baseline

Quantitative measurements in lumbar magnetic resonance imaging

Timeframe: Three months after the technic

Qualitative changes in lumbar magnetic resonance imaging

Timeframe: Baseline

Qualitative changes in lumbar magnetic resonance imaging

Timeframe: three months after the technic

Numerical rating scale

Timeframe: Baseline

Numerical rating scale

Timeframe: 1 month after the technic

Numerical rating scale

Timeframe: 3 months after the technic

Numerical rating scale

Timeframe: 6 months after the technic