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Completed

NCT Number: NCT03863067

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

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.

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Key information

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epiduroscopy

Procedure

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

Other names: Spinal endoscopy

Primary outcomes

  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. EuroQualityofLife 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. EuroQualityofLife 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. EuroQualityofLife visual analogue scale (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. EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

    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. EuroQualityofLife visual analogue scale (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. EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

    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. EuroQualityofLife visual analogue scale (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. EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

    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. EuroQualityofLife visual analogue scale (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. EuroQualityofLife Five-Dimensions Five-Levels Questionnaire(EQ-5D-5L)

    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:

    • 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.

  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:

    • 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.

  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:

    • 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.

  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:

    • 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.

  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:

    • 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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study title

Assessment Of Clinical Effectiveness, Security And Correlation With Radiological Changes In Patients With Lumbar Stenosis Treated With Epiduroscopy

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2019
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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