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

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ClinicalTrials.gov Identifier: NCT03863067
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Procedure: Epiduroscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment Of Clinical Effectiveness, Security And Correlation With Radiological Changes In Patients With Lumbar Stenosis Treated With Epiduroscopy
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Lumbar spinal stenosis patients
Epiduroscopy in patients with lumbar spinal stenosis
Procedure: Epiduroscopy
Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.
Other Name: Spinal endoscopy




Primary Outcome Measures :
  1. Quantitative measurements in lumbar magnetic resonance imaging [ Time Frame: Baseline ]
    Measure in mm of ligamentum flavum at the level with major stenosis at the medium area of the ligamentum and in the recess

  2. Quantitative measurements in lumbar magnetic resonance imaging [ Time Frame: 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

  3. Qualitative changes in lumbar magnetic resonance imaging [ Time Frame: Baseline ]
    Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis

  4. Qualitative changes in lumbar magnetic resonance imaging [ Time Frame: three months after the technic ]
    Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis

  5. Numerical rating scale [ Time Frame: Baseline ]
    Pain from 0 (no pain) to 10 (worst pain imaginable)

  6. Numerical rating scale [ Time Frame: 1 month after the technic ]
    Pain from 0 (no pain) to 10 (worst pain imaginable)

  7. Numerical rating scale [ Time Frame: 3 months after the technic ]
    Pain from 0 (no pain) to 10 (worst pain imaginable)

  8. Numerical rating scale [ Time Frame: 6 months after the technic ]
    Pain from 0 (no pain) to 10 (worst pain imaginable)

  9. Numerical rating scale [ Time Frame: 12 months after the technic ]
    Pain from 0 (no pain) to 10 (worst pain imaginable)

  10. Likert Scale to record the percentage of improvement [ Time Frame: baseline ]
    Percentage of improvement: 1 (>75% worst) 2 >50% worst; 3 (>25% worst); 4 (no changes); 5 ( 25% better); 6 (50% better); 7 (75% better)

  11. Likert Scale to record the percentage of improvement [ Time Frame: 1 month 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)

  12. Likert Scale to record the percentage of improvement [ Time Frame: 3 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)

  13. Likert Scale to record the percentage of improvement [ Time Frame: 6 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)

  14. Likert Scale to record the percentage of improvement [ Time Frame: 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)

  15. EuroQol visual analogue scale (EQ VAS) [ Time Frame: Baseline ]
    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.

  16. EuroQol Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L) [ Time Frame: Baseline ]

    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.


  17. EQ VAS [ Time Frame: 1 month 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.

  18. EQ5D5L Questionnaire [ Time Frame: 1 month 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.


  19. EQ VAS [ Time Frame: 3 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.

  20. EQ5D5L Questionnaire [ Time Frame: 3 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.


  21. EQ VAS [ Time Frame: 6 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.

  22. EQ5D5L Questionnaire [ Time Frame: 6 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.


  23. EQ VAS [ Time Frame: 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.

  24. EQ5D5L Questionnaire [ Time Frame: 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.


  25. Oswestry Disability Index (ODI) [ Time Frame: Baseline ]
    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

  26. Oswestry Disability Index (ODI) [ Time Frame: 1 month 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

  27. Oswestry Disability Index (ODI) [ Time Frame: 3 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

  28. Oswestry Disability Index (ODI) [ Time Frame: 6 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

  29. Oswestry Disability Index (ODI) [ Time Frame: 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

  30. Zurich questionnaire [ Time Frame: Baseline ]

    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.

  31. Zurich questionnaire [ Time Frame: 1 month 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.

  32. Zurich questionnaire [ Time Frame: 3 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.

  33. Zurich questionnaire [ Time Frame: 6 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.

  34. Zurich questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863067


Contacts
Layout table for location contacts
Contact: EVA M MONZON, MD 0034667750949 draevamonzon@gmail.com
Contact: LUCIA LLANOS, MD, PHD 003491 5504800 ext 3214 lucia.llanos@fjd.es

Locations
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Spain
Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: lucia llanos, md, phd    91 5504800 ext 3214    lucia.llanos@fjd.es   
Principal Investigator: eva m monzon, md         
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Investigators
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Study Director: DAVID ABEJON, MD, PHD HOSPITAL QUIRONSALUD MADRID

Publications:
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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT03863067     History of Changes
Other Study ID Numbers: PIC131-18
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
Lumbosacral epiduroscopy
spinal stenosis
magnetic resonance imaging
intraoperative neurophysiological monitoring
neurogenic claudication

Additional relevant MeSH terms:
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Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases