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

Not Applicable

Completed

• Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

• Registration Number: NCT03863067
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.

Study Timeline

• Study Start: 2018-10-15
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)	12 months after	The 5-level EQ-5D version (EQ-5D-5L) consists of: The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
EuroQualityofLife visual analogue scale (EQ VAS)	12 months after	The EQ visual analogue scale (EQ VAS). VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints wich comes from 0 to 100 are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). This can be used as a quantitative measure of health outcome. The higher values indicates a better outcome.
Zurich questionnaire	12 months after	Claudication test:The scale relates to symptoms over the past month. There are 12 questions for all patients, and a further 6 questions to measure treatment outcome (for those who have had treatment).; The The Zurich Claudication Questionnaire consists of three subscales: 1. Symptom severity scale (questions I-VII) \[further subdivided into pain domain (questions I-IV) and a neuroischemic domain (questions V-VII)\]: Possible range of the score is 1 to 5.; 2. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4.; 3. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
Oswestry Disability Index (ODI)	12 months after	Low back pain disability questionnaire: is a validated, 10-point patient-reported outcome questionnaire. It is considered the 'gold standard' for measuring disability and quality of life (QoL) impairment for adults with low back pain (LBP).The 10 factors which constitute the ODI criteria for assessing patients' functional impairment are pain intensity, ease of personal care, lifting, working, sitting, stand-ing, sleeping, sex life, social life and travelling. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0-20, minimal disability; 21-40, moderate disability; 41-60, severe disability; 61-80, crippling back pain; 81-100, these patients are either bed-bound or have an exaggeration of their symptoms. In order for the results to be deemed clinically significant, a change in the patient's score of 10% or more is required
Quantitative measurements in lumbar magnetic resonance imaging	Three months after the technic	Measure in mm of ligamentum flavum at the level with major stenosis at the medium area of the ligamentum and in the recess
Likert Scale to record the percentage of improvement	12 months after the technic	Percentage of improvement: 1 (\>75% worst) 2 \>50% worst; 3 (\>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)
Qualitative changes in lumbar magnetic resonance imaging	three months after the technic	Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Numerical rating scale	12 months after the technic	Pain from 0 (no pain) to 10 (worst pain imaginable)

Trial Locations

Locations (1)

Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain