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

NCT ID: NCT03863067

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2022-10-15

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 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.

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 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.

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumbar spinal stenosis patients

Epiduroscopy in patients with lumbar spinal stenosis

Group Type: EXPERIMENTAL

Epiduroscopy

Intervention Type: PROCEDURE

Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.

Interventions

Epiduroscopy

Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.

Intervention Type: PROCEDURE

Other Intervention Names

Spinal endoscopy

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DAVID ABEJON, MD, PHD

Role: STUDY_DIRECTOR

HOSPITAL QUIRONSALUD MADRID

Locations

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

Madrid, , Spain

Countries

Spain

References

Manchikanti L, Saini B, Singh V. Spinal endoscopy and lysis of epidural adhesions in the management of chronic low back pain. Pain Physician. 2001 Jul;4(3):240-65.

Reference Type: BACKGROUND

PMID: 16900252 (View on PubMed)

Raffaeli W, Righetti D, Andruccioli J, Sarti D. Periduroscopy: general review of clinical features and development of operative models. Acta Neurochir Suppl. 2011;108:55-65. doi: 10.1007/978-3-211-99370-5_10.

Reference Type: BACKGROUND

PMID: 21107939 (View on PubMed)

Deyo RA. Treatment of lumbar spinal stenosis: a balancing act. Spine J. 2010 Jul;10(7):625-7. doi: 10.1016/j.spinee.2010.05.006.

Reference Type: BACKGROUND

PMID: 20620984 (View on PubMed)

Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009 Jul;9(7):545-50. doi: 10.1016/j.spinee.2009.03.005. Epub 2009 Apr 23.

Reference Type: BACKGROUND

PMID: 19398386 (View on PubMed)

Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.

Reference Type: BACKGROUND

PMID: 17445736 (View on PubMed)

Raffaeli W, Righetti D. Surgical radio-frequency epiduroscopy technique (R-ResAblator) and FBSS treatment: preliminary evaluations. Acta Neurochir Suppl. 2005;92:121-5. doi: 10.1007/3-211-27458-8_26.

Reference Type: BACKGROUND

PMID: 15830982 (View on PubMed)

Monzon EM, Rios A, Carrascoso J, Moreno P, Abejon D. Epiduroscopy in spinal stenosis. Description of the procedure and safety measures to reduce complications. Pain Manag. 2025 Sep 8:1-8. doi: 10.1080/17581869.2025.2552636. Online ahead of print.

Reference Type: DERIVED

PMID: 40920478 (View on PubMed)

Other Identifiers

PIC131-18

Identifier Type: -

Identifier Source: org_study_id