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

NCT03863067 | Completed

• 1 other identifier: PIC131-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Keywords

Lumbosacral epiduroscopy; spinal stenosis; magnetic resonance imaging; intraoperative neurophysiological monitoring; neurogenic claudication

Outcome Measures

Primary Outcomes (34)

• Quantitative measurements in lumbar magnetic resonance imaging

  Measure in mm of ligamentum flavum at the level with major stenosis at the medium area of the ligamentum and in the recess

  Baseline

• Quantitative measurements in lumbar magnetic resonance imaging

  Measure in mm of ligamentum flavum at the level with major stenosis at the medium area of the ligamentum and in the recess

  Three months after the technic

• Qualitative changes in lumbar magnetic resonance imaging

  Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis

  Baseline

• Qualitative changes in lumbar magnetic resonance imaging

  Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis

  three months after the technic

• Numerical rating scale

  Pain from 0 (no pain) to 10 (worst pain imaginable)

  Baseline

• Numerical rating scale

  Pain from 0 (no pain) to 10 (worst pain imaginable)

  1 month after the technic

• Numerical rating scale

  Pain from 0 (no pain) to 10 (worst pain imaginable)

  3 months after the technic

• Numerical rating scale

  Pain from 0 (no pain) to 10 (worst pain imaginable)

  6 months after the technic

• Numerical rating scale

  Pain from 0 (no pain) to 10 (worst pain imaginable)

  12 months after the technic

• Likert Scale to record the percentage of improvement

  Percentage of improvement: 1 (\>75% worst) 2 \>50% worst; 3 (\>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)

  baseline

• Likert Scale to record the percentage of improvement

  Percentage of improvement: 1 (\>75% worst) 2 \>50% worst; 3 (\>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)

  1 month after the technic

• Likert Scale to record the percentage of improvement

  Percentage of improvement: 1 (\>75% worst) 2 \>50% worst; 3 (\>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)

  3 months after the technic

• Likert Scale to record the percentage of improvement

  Percentage of improvement: 1 (\>75% worst) 2 \>50% worst; 3 (\>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)

  6 months after the technic

• Likert Scale to record the percentage of improvement

  Percentage of improvement: 1 (\>75% worst) 2 \>50% worst; 3 (\>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)

  12 months after the technic

• EuroQualityofLife visual analogue scale (EQ VAS)

  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.

  Baseline

• EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

  The 5-level EQ-5D version (EQ-5D-5L) consists of: 1- 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.

  Baseline

• EuroQualityofLife visual analogue scale (EQ VAS)

  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.

  1 month after

• EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

  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.

  1 month after

• EuroQualityofLife visual analogue scale (EQ VAS)

  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.

  3 months after

• EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

  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.

  3 months after

• EuroQualityofLife visual analogue scale (EQ VAS)

  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.

  6 months after

• EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

  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.

  6 months after

• EuroQualityofLife visual analogue scale (EQ VAS)

  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.

  12 months after

• EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

  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.

  12 months after

• Oswestry Disability Index (ODI)

  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

  Baseline

• Oswestry Disability Index (ODI)

  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

  1 month after

• Oswestry Disability Index (ODI)

  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

  3 months after

• Oswestry Disability Index (ODI)

  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

  6 months after

• Oswestry Disability Index (ODI)

  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

  12 months after

• Zurich questionnaire

  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.

  Baseline

• Zurich questionnaire

  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.

  1 month after

• Zurich questionnaire

  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.

  3 months after

• Zurich questionnaire

  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.

  6 months after

• Zurich questionnaire

  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.

  12 months after

Study Arms (1)

Lumbar spinal stenosis patients

EXPERIMENTAL

Epiduroscopy in patients with lumbar spinal stenosis

Procedure: Epiduroscopy

Interventions

Epiduroscopy PROCEDURE

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

Also known as: Spinal endoscopy

Lumbar spinal stenosis patients

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

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

Madrid, 28040, Spain

Location

Related Publications (7)

• 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.

  PMID: 16900252 BACKGROUND

• 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.

  PMID: 21107939 BACKGROUND

• 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.

  PMID: 20620984 BACKGROUND

• 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.

  PMID: 19398386 BACKGROUND

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

  PMID: 17445736 BACKGROUND

• 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.

  PMID: 15830982 BACKGROUND

• 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 Nov;15(11):827-834. doi: 10.1080/17581869.2025.2552636. Epub 2025 Sep 8.

  PMID: 40920478 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• DAVID ABEJON, MD, PHD

  HOSPITAL QUIRONSALUD MADRID

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: March 5, 2019
• Study Start: October 15, 2018
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

ES (1)