Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationNCT03863067
Clinical Effectiveness, Security And Radiological Changes In Epiduroscopy For Lumbar Stenosis
A study testing Epiduroscopy in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
- What is being tested?
- Epiduroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2018to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric disorders
- Opioid addiction
- Acute organic disease
- Severe chronic organic disease
- Vasculo-cerebral disease
- Coagulation alterations
Show all 10Show fewer
- Ofthalmologic disease
- Allergic
- Infections
- Impossibility to understand the procedure
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investigación Clínica Secretaría Técnica CEImFJD Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
About this study
Official title: 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.
Read the 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.
- Being tested
- Epiduroscopy
- Keywords
- Lumbosacral epiduroscopy, spinal stenosis, magnetic resonance imaging, intraoperative neurophysiological monitoring, neurogenic claudication
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduroscopyProcedure or surgery
Also called Spinal endoscopy
Using epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spinal stenosis patients | Experimental | Epiduroscopy in patients with lumbar spinal stenosis Receives: Procedure: Epiduroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Three months after the technic
Qualitative changes in lumbar magnetic resonance imaging
Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Measured: Baseline
Qualitative changes in lumbar magnetic resonance imaging
Schizas classification( A:no stenosis, B: moderate; C:severe) at the level where there are major stenosis
Measured: three months after the technic
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Measured: Baseline
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Measured: 1 month after the technic
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Measured: 3 months after the technic
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Measured: 6 months after the technic
Numerical rating scale
Pain from 0 (no pain) to 10 (worst pain imaginable)
Measured: 12 months after the technic
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)
Measured: baseline
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)
Measured: 1 month after the technic
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)
Measured: 3 months after the technic
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)
Measured: 6 months after the technic
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)
Measured: 12 months after the technic
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: 1 month after
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.
Measured: 1 month after
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.
Measured: 3 months after
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.
Measured: 3 months after
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.
Measured: 6 months after
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.
Measured: 6 months after
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.
Measured: 12 months after
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.
Measured: 12 months after
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
Measured: Baseline
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
Measured: 1 month after
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
Measured: 3 months after
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
Measured: 6 months after
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
Measured: 12 months after
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.
Measured: Baseline
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.
Measured: 1 month after
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.
Measured: 3 months after
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.
Measured: 6 months after
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.
Measured: 12 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Oct 2018
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID ABEJON, MD, PHD, Study director, HOSPITAL QUIRONSALUD MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863067
- Sponsor's protocol ID
- PIC131-18
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2019
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16900252Raffaeli 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.
PubMed 21107939Deyo 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.
PubMed 20620984Kalichman 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.
PubMed 19398386Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.
PubMed 17445736Raffaeli 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.
PubMed 15830982Monzon EM, Rios A, Carrascoso J, Moreno P, Abejon D. Epiduroscopy in spinal stenosis. Description of the procedure and safety measures to reduce complications. Pain Manag. 2025 Nov;15(11):827-834. doi: 10.1080/17581869.2025.2552636. Epub 2025 Sep 8.
PubMed 40920478
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Clinical Effectiveness, Security And Correlation With Radiological Changes In Patients With Lumbar Stenosis Treated With Epiduroscopy
- ClinicalTrials.gov ID
- NCT03863067
- Acronym / sponsor ID
- PIC131-18
- Keywords
- Lumbosacral epiduroscopy, spinal stenosis, magnetic resonance imaging, intraoperative neurophysiological monitoring, neurogenic claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar spinal stenosis patients | Experimental | Procedure: EpiduroscopyEpiduroscopy in patients with lumbar spinal stenosis |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Psychiatric disorders
- Opioid addiction
- Acute organic disease
- Severe chronic organic disease
- Vasculo-cerebral disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiduroscopyAlso: Spinal endoscopyUsing epiduroscopy to treat the ligamentum flavum hypertrophy with Resaflex ,an instrument with Quantum Molecular Resonance for tissue coablation. | Procedure or surgery | Lumbar spinal stenosis patients |
Primary outcome
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
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
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
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
Numerical rating scale
Time frame: Baseline
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Time frame: 1 month after the technic
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Time frame: 3 months after the technic
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Time frame: 6 months after the technic
Pain from 0 (no pain) to 10 (worst pain imaginable)
Numerical rating scale
Time frame: 12 months after the technic
Pain from 0 (no pain) to 10 (worst pain imaginable)
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 16900252Manchikanti 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.
- Background: PubMed 21107939Raffaeli 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.
- Background: PubMed 20620984Deyo 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.
- Background: PubMed 19398386Kalichman 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.
- Background: PubMed 17445736Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.
- Background: PubMed 15830982Raffaeli 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.
- Derived from this study: PubMed 40920478Monzon EM, Rios A, Carrascoso J, Moreno P, Abejon D. Epiduroscopy in spinal stenosis. Description of the procedure and safety measures to reduce complications. Pain Manag. 2025 Nov;15(11):827-834. doi: 10.1080/17581869.2025.2552636. Epub 2025 Sep 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAVID ABEJON, MD, PHD study director
HOSPITAL QUIRONSALUD MADRID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epiduroscopy in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measurements in lumbar magnetic resonance imaging (time frame: Baseline). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863067, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.