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

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863067
• Other study ID #: PIC131-18
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: October 15, 2022

Study information

• Verified date: March 2024
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intermittent Claudication
• Spinal Stenosis
• Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Intervention

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

Locations

Country	Name	City	State
Spain	Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Numerical rating scale	Pain from 0 (no pain) to 10 (worst pain imaginable)	Baseline
Primary	Numerical rating scale	Pain from 0 (no pain) to 10 (worst pain imaginable)	1 month after the technic
Primary	Numerical rating scale	Pain from 0 (no pain) to 10 (worst pain imaginable)	3 months after the technic
Primary	Numerical rating scale	Pain from 0 (no pain) to 10 (worst pain imaginable)	6 months after the technic
Primary	Numerical rating scale	Pain from 0 (no pain) to 10 (worst pain imaginable)	12 months after the technic
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	Baseline
Primary	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.	1 month after
Primary	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.	3 months after
Primary	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.	6 months after
Primary	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.	12 months after