- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863067
Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis
Assessment Of Clinical Effectiveness, Security And Correlation With Radiological Changes In Patients With Lumbar Stenosis Treated With Epiduroscopy
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: EVA M MONZON, MD
- Phone Number: 0034667750949
- Email: draevamonzon@gmail.com
Study Contact Backup
- Name: LUCIA LLANOS, MD, PHD
- Phone Number: 3214 003491 5504800
- Email: lucia.llanos@fjd.es
Study Locations
-
-
-
Madrid, Spain, 28040
- Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lumbar spinal stenosis patients
Epiduroscopy in patients with lumbar spinal stenosis
|
Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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
|
Three months after the technic
|
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
|
Baseline
|
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
|
three months after the technic
|
Numerical rating scale
Time Frame: Baseline
|
Pain from 0 (no pain) to 10 (worst pain imaginable)
|
Baseline
|
Numerical rating scale
Time Frame: 1 month after the technic
|
Pain from 0 (no pain) to 10 (worst pain imaginable)
|
1 month after the technic
|
Numerical rating scale
Time Frame: 3 months after the technic
|
Pain from 0 (no pain) to 10 (worst pain imaginable)
|
3 months after the technic
|
Numerical rating scale
Time Frame: 6 months after the technic
|
Pain from 0 (no pain) to 10 (worst pain imaginable)
|
6 months after the technic
|
Numerical rating scale
Time Frame: 12 months after the technic
|
Pain from 0 (no pain) to 10 (worst pain imaginable)
|
12 months after the technic
|
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)
|
baseline
|
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)
|
1 month after the technic
|
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)
|
3 months after the technic
|
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)
|
6 months after the technic
|
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)
|
12 months after the technic
|
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.
|
Baseline
|
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. |
Baseline
|
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.
|
1 month after
|
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. |
1 month after
|
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.
|
3 months after
|
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. |
3 months after
|
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.
|
6 months after
|
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. |
6 months after
|
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.
|
12 months after
|
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. |
12 months after
|
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
|
Baseline
|
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
|
1 month after
|
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
|
3 months after
|
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
|
6 months after
|
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
|
12 months after
|
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:
|
Baseline
|
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 month after
|
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:
|
3 months after
|
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:
|
6 months after
|
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:
|
12 months after
|
Collaborators and Investigators
Investigators
- Study Director: DAVID ABEJON, MD, PHD, Hospital Quirónsalud Madrid
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIC131-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
-
Vertos Medical, Inc.Active, not recruitingSpinal Stenosis, Lumbar Region, With Neurogenic ClaudicationUnited States
-
VertiFlex, IncorporatedWithdrawnSpinal Stenosis, Lumbar Region With Neurogenic ClaudicationUnited States
-
Vertos Medical, Inc.Completed
-
Marshfield Clinic Research FoundationTerminatedSpinal Stenosis, Lumbar Region, With Neurogenic ClaudicationUnited States
-
Uppsala UniversityCompletedSpinal Stenosis | Spinal Stenosis Lumbar | Degeneration Spine | Degeneration Lumbar Spine | Neurogenic Claudication Co-Occurrent and Due to Spinal Stenosis of Lumbar Region | Pseudoclaudication SyndromeSweden
-
Novosibirsk Research Institute of Traumatology...TerminatedSpinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)Russian Federation
-
Innovative Surgical DesignsSuspendedLumbar Spinal Stenosis | Spondylolisthesis, Grade 1 | Neurogenic ClaudicationUnited States
-
Asan Medical CenterActive, not recruitingSarcopenia | Lumbar Spinal Stenosis | Neurogenic ClaudicationKorea, Republic of
-
Yungjin Pharm. Co., Ltd.CompletedNeurologic Claudication in Patients With Lumbar Spinal StenosisKorea, Republic of
-
Assuta Medical CenterUnknownSpinal Stenosis Lumbar | Spondylolisthesis | Degeneration Spine | Fusion of Spine, Lumbar RegionIsrael
Clinical Trials on Epiduroscopy
-
University of Sao PauloCompletedLow Back Pain | Failed Back Surgery SyndromeBrazil
-
Pavol Jozef Safarik UniversityEuropainclinics z.ú.Unknown
-
Europainclinics z.ú.Brno University Hospital; Pavol Jozef Safarik University; Slovak Academy of SciencesCompleted
-
Europainclinics z.ú.Completed