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

Primary Purpose

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Epiduroscopy
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication focused on measuring Lumbosacral epiduroscopy, spinal stenosis, magnetic resonance imaging, intraoperative neurophysiological monitoring, neurogenic claudication

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez DíazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumbar spinal stenosis patients

Arm Description

Epiduroscopy in patients with lumbar spinal stenosis

Outcomes

Primary Outcome Measures

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
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
Qualitative changes in lumbar magnetic resonance imaging
Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Qualitative changes in lumbar magnetic resonance imaging
Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2019
Last Updated
October 14, 2021
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT03863067
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Keywords
Lumbosacral epiduroscopy, spinal stenosis, magnetic resonance imaging, intraoperative neurophysiological monitoring, neurogenic claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbar spinal stenosis patients
Arm Type
Experimental
Arm Description
Epiduroscopy in patients with lumbar spinal stenosis
Intervention Type
Procedure
Intervention Name(s)
Epiduroscopy
Other Intervention Name(s)
Spinal endoscopy
Intervention Description
Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.
Primary Outcome Measure Information:
Title
Quantitative measurements in lumbar magnetic resonance imaging
Description
Measure in mm of ligamentum flavum at the level with major stenosis at the medium area of the ligamentum and in the recess
Time Frame
Baseline
Title
Quantitative measurements in lumbar magnetic resonance imaging
Description
Measure in mm of ligamentum flavum at the level with major stenosis at the medium area of the ligamentum and in the recess
Time Frame
Three months after the technic
Title
Qualitative changes in lumbar magnetic resonance imaging
Description
Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Time Frame
Baseline
Title
Qualitative changes in lumbar magnetic resonance imaging
Description
Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Time Frame
three months after the technic
Title
Numerical rating scale
Description
Pain from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
Baseline
Title
Numerical rating scale
Description
Pain from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
1 month after the technic
Title
Numerical rating scale
Description
Pain from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
3 months after the technic
Title
Numerical rating scale
Description
Pain from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
6 months after the technic
Title
Numerical rating scale
Description
Pain from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
12 months after the technic
Title
Likert Scale to record the percentage of improvement
Description
Percentage of improvement: 1 (>75% worst) 2 >50% worst; 3 (>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)
Time Frame
baseline
Title
Likert Scale to record the percentage of improvement
Description
Percentage of improvement: 1 (>75% worst) 2 >50% worst; 3 (>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)
Time Frame
1 month after the technic
Title
Likert Scale to record the percentage of improvement
Description
Percentage of improvement: 1 (>75% worst) 2 >50% worst; 3 (>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)
Time Frame
3 months after the technic
Title
Likert Scale to record the percentage of improvement
Description
Percentage of improvement: 1 (>75% worst) 2 >50% worst; 3 (>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)
Time Frame
6 months after the technic
Title
Likert Scale to record the percentage of improvement
Description
Percentage of improvement: 1 (>75% worst) 2 >50% worst; 3 (>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)
Time Frame
12 months after the technic
Title
EuroQualityofLife visual analogue scale (EQ VAS)
Description
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.
Time Frame
Baseline
Title
EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
Description
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.
Time Frame
Baseline
Title
EuroQualityofLife visual analogue scale (EQ VAS)
Description
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.
Time Frame
1 month after
Title
EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
Description
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.
Time Frame
1 month after
Title
EuroQualityofLife visual analogue scale (EQ VAS)
Description
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.
Time Frame
3 months after
Title
EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
Description
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.
Time Frame
3 months after
Title
EuroQualityofLife visual analogue scale (EQ VAS)
Description
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.
Time Frame
6 months after
Title
EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
Description
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.
Time Frame
6 months after
Title
EuroQualityofLife visual analogue scale (EQ VAS)
Description
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.
Time Frame
12 months after
Title
EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)
Description
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.
Time Frame
12 months after
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
Baseline
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
1 month after
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
3 months after
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
6 months after
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
12 months after
Title
Zurich questionnaire
Description
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
Time Frame
Baseline
Title
Zurich questionnaire
Description
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
Time Frame
1 month after
Title
Zurich questionnaire
Description
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
Time Frame
3 months after
Title
Zurich questionnaire
Description
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
Time Frame
6 months after
Title
Zurich questionnaire
Description
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: 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. Physical function scale (questions VIII-XII): Possible range of scores is 1 to 4. Patient's satisfaction with treatment scale (questions XIII-XVIII): the range of the scale is 1 to 4.
Time Frame
12 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EVA M MONZON, MD
Phone
0034667750949
Email
draevamonzon@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
LUCIA LLANOS, MD, PHD
Phone
003491 5504800
Ext
3214
Email
lucia.llanos@fjd.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAVID ABEJON, MD, PHD
Organizational Affiliation
HOSPITAL QUIRONSALUD MADRID
Official's Role
Study Director
Facility Information:
Facility Name
Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lucia llanos, md, phd
Phone
91 5504800
Ext
3214
Email
lucia.llanos@fjd.es
First Name & Middle Initial & Last Name & Degree
eva m monzon, md

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16900252
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.
Results Reference
background
PubMed Identifier
21107939
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.
Results Reference
background
PubMed Identifier
20620984
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.
Results Reference
background
PubMed Identifier
19398386
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.
Results Reference
background
PubMed Identifier
17445736
Citation
Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.
Results Reference
background
PubMed Identifier
15830982
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.
Results Reference
background

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

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