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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Completed

Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Treatments: Procedure: Epiduroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03863067

PIC131-18

Details and patient eligibility

About

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.

Full 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 of different frequencies in the range of the radio-frequency, emit quantum in resonance and produce lesion and coagulation; The objective is to reach the ligamentum flavum doing lesions to diminish the stenosis caused by hypertrophic ligamentum over all in the recess area near the radicular nerve.

To increase the security of the procedure the investigators introduce for the first time , neurophysiological monitoring.

Enrollment: 40 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Lumbar spinal stenosis patients

Experimental group

Description:

Epiduroscopy in patients with lumbar spinal stenosis

Treatment:

Procedure: Epiduroscopy