Clinical trial NCT03863067: Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis
Official title: Assessment Of Clinical Effectiveness, Security And Correlation With Radiological Changes In Patients With Lumbar Stenosis Treated With Epiduroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Keywords: Lumbosacral epiduroscopy
spinal stenosis
magnetic resonance imaging
intraoperative neurophysiological monitoring
neurogenic claudication
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quantitative measurements in lumbar magnetic resonance imaging
timeFrame: Baseline
measure: Quantitative measurements in lumbar magnetic resonance imaging
timeFrame: Three months after the technic
measure: Qualitative changes in lumbar magnetic resonance imaging
timeFrame: Baseline
measure: Qualitative changes in lumbar magnetic resonance imaging
timeFrame: three months after the technic
measure: Numerical rating scale
timeFrame: Baseline
measure: Numerical rating scale
timeFrame: 1 month after the technic
measure: Numerical rating scale
timeFrame: 3 months after the technic
measure: Numerical rating scale
timeFrame: 6 months after the technic
measure: Numerical rating scale
timeFrame: 12 months after the technic
measure: Likert Scale to record the percentage of improvement
timeFrame: baseline
measure: Likert Scale to record the percentage of improvement
timeFrame: 1 month after the technic
measure: Likert Scale to record the percentage of improvement
timeFrame: 3 months after the technic
measure: Likert Scale to record the percentage of improvement
timeFrame: 6 months after the technic
measure: Likert Scale to record the percentage of improvement
timeFrame: 12 months after the technic
measure: EuroQualityofLife visual analogue scale (EQ VAS)
timeFrame: Baseline
measure: EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
timeFrame: Baseline
measure: EuroQualityofLife visual analogue scale (EQ VAS)
timeFrame: 1 month after
measure: EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
timeFrame: 1 month after
measure: EuroQualityofLife visual analogue scale (EQ VAS)
timeFrame: 3 months after
measure: EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
timeFrame: 3 months after
measure: EuroQualityofLife visual analogue scale (EQ VAS)
timeFrame: 6 months after
measure: EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
timeFrame: 6 months after
measure: EuroQualityofLife visual analogue scale (EQ VAS)
timeFrame: 12 months after
measure: EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
timeFrame: 12 months after
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline
measure: Oswestry Disability Index (ODI)
timeFrame: 1 month after
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months after
measure: Oswestry Disability Index (ODI)
timeFrame: 6 months after
measure: Oswestry Disability Index (ODI)
timeFrame: 12 months after
measure: Zurich questionnaire
timeFrame: Baseline
measure: Zurich questionnaire
timeFrame: 1 month after
measure: Zurich questionnaire
timeFrame: 3 months after
measure: Zurich questionnaire
timeFrame: 6 months after
measure: Zurich questionnaire
timeFrame: 12 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz
Study officials:
affiliation: HOSPITAL QUIRONSALUD MADRID
name: DAVID ABEJON, MD, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.
citation: 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.