Lumbar Disc DiseaseNCT02185508
Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.
An observational study of Lumbar Disc Disease, run by American British Cowdray Medical Center at 1 site in Mexico.
Trial summary
The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Disc Disease
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2011to Aug 2014
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with lumbar disk disease with radiculopathy, undergoing neurological surgery of the spine at the ABC Neurological Center
Who may be able to join
- Diagnosis of Lumbar Disk Disease
- Clinical Signs of Radiculopathy
- Undergoing neurological surgery of the spine
Who cannot join
- Previous neurological surgery of the lumbar spine
- More than 2 levels intervened at the surgery
- Serious post-operatory complications
Trial locations and contacts
1 site in 1 country.
Mexico1 site
American British Cowdray Medical Center
Mexico City, Mexico City, 05300
About this study
Official title: Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Radiculopathy Associated to Lumbar Disk Disease. Two Years Follow-up
The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine.
IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are:
Read more
- Somatosensory evoked potentials (SSEPs).
- Trans-cranial electric motor evoked potentials (tceMEPs).
- Spontaneous electromyography (EMG).
Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales:
- Oswestry Disability Index 2.1a
- Visual Analogue Scale for Pain
- Patient's Overall Impression of Change
Read the detailed description
Radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine surgeon to be consulted. The pathophysiology of degenerative spine disease is acknowledged as complex, involving a wide array of risk factors ranging from genetic polymorphisms, to behavioural characteristics. While conflicting opinions exist with regard the direction of treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for patients in which protocols of physiotherapy and analgesics have failed to comply.
Intraoperative neurophysiological monitoring (IONM) is widely used in the practice of spine surgery as a mean of preventing and reducing severe complications inherent to surgical techniques like paraparesis, paraplegia and quadriplegia. Indeed, a great deal of funding and work have been devoted to research projects seeking to determine the impact of IONM in reducing these risks. The results of such projects have been notoriously interesting, and frequently opposing to each other. This has lead to an open debate on weather the use of IONM may or not be justified by better outcomes in patients who undergo such procedure. To our knowledge there is no study in the literature that has addressed the potential role of the IOM to predict the long-term outcome of the patient in therms of radicular symptoms improvement.
- Conditions
- Lumbar Disc Disease
- Keywords
- IONM, Lumbar Disk Disease, Degenerative Spine Disease, Radiculopathy, Intraoperative Neurophysiological Monitoring, Somatosensory Evoked Potentials, Electromyography
- Medical subject headings
- Intervertebral disc disease, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spine surgery with IONM | Patients diagnosed with 1 or 2 level lumbar disk disease and radicular symptoms who underwent decompressive surgery, and for whom IONM records exist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological changes measured through intraoperative neurophysiological monitoring.
Standard register electrodes where placed from L1 to L5 myotomes and dermatomes. Through trans-operative real time modalities (trans-cranial electric motor evoked potentials, somatosensory evoked potentials, and spontaneous electromyography) measurements on amplitude and voltage were recorded at the beginning and at the end of the spinal decompression. This change will be studied to determine its predictive power in the clinical long-term outcome of the patients.
Measured: Trans-operative
Secondary outcomes (3)
Visual analogue scale for pain
The visual analogue scale is a written survey used to assess the pain a person endures. The patient will select a number from one to ten to express the relative amount of pain she is suffering. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is <5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey
Measured: In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Visual Analogue Scale for Pain
Oswestry Disability Index 2.1a
The Oswestry Disability Index 2.1a is a written survey used to quantify the amount of disability a person endures due to low-back pain. The patient will answer a series of 10 questions enquiring about experiences of her life, and how the pain she suffers affects the quality of these experiences. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is <5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey.
Measured: In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Oswestry Disability Index 2.1a
Patient's Global Impression of Change Survey
The Patient's Global Impression of Change Survey is a written survey used to quantify the amount of improvement a person perceives for herself after receiving a certain treatment. The patient will select from a list of previously defined statements, the one that best describes her impression of change after the surgery, and will select a number ranging from one to ten representing her perception of improvement. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is <5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey.
Measured: In the follow-up visits up to two years after the completion of the neurological surgery, the patient will be asked to complete the Patient's Global Impression of Change Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American British Cowdray Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galvan Ernesto Eduardo, American British Cowdray Medical Center
- Investigators
- Roberto De Leo Vargas, MD, Study director, American British Cowdray Medical CenterMaximino Tellez, MD, Study chair, American British Cowdray Medical CenterIldefonso Muñoz Romero, MD, Study chair, American British Cowdray Medical CenterMiguel Angel Collado Corona, MD, Study chair, American British Cowdray Medical CenterLeopoldo Torres Vyera, MD, Study chair, American British Cowdray Medical CenterChristian Cerecedo, MD, Study chair, American British Cowdray Medical CenterEduardo Galvan Hernandez, MD, Principal investigator, American British Cowdray Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185508
- Sponsor's protocol ID
- ABC-14-06
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
Publications
Koerner JD, Glaser J, Radcliff K. Which Variables Are Associated With Patient-reported Outcomes After Discectomy? Review of SPORT Disc Herniation Studies. Clin Orthop Relat Res. 2015 Jun;473(6):2000-6. doi: 10.1007/s11999-014-3671-1.
PubMed 24818737Sabnis AB, Diwan AD. The timing of surgery in lumbar disc prolapse: A systematic review. Indian J Orthop. 2014 Mar;48(2):127-35. doi: 10.4103/0019-5413.128740.
PubMed 24741132
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Radiculopathy Associated to Lumbar Disk Disease. Two Years Follow-up
- ClinicalTrials.gov ID
- NCT02185508
- Acronym / sponsor ID
- ABC-14-06
- Conditions
- Lumbar Disc Disease
- Keywords
- IONM, Lumbar Disk Disease, Degenerative Spine Disease, Radiculopathy, Intraoperative Neurophysiological Monitoring, Somatosensory Evoked Potentials, Electromyography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- American British Cowdray Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- 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.
The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine.
IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are:
- Somatosensory evoked potentials (SSEPs).
- Trans-cranial electric motor evoked potentials (tceMEPs).
- Spontaneous electromyography (EMG).
Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales:
- Oswestry Disability Index 2.1a
- Visual Analogue Scale for Pain
- Patient's Overall Impression of Change
Detailed description
Radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine surgeon to be consulted. The pathophysiology of degenerative spine disease is acknowledged as complex, involving a wide array of risk factors ranging from genetic polymorphisms, to behavioural characteristics. While conflicting opinions exist with regard the direction of treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for patients in which protocols of physiotherapy and analgesics have failed to comply.
Intraoperative neurophysiological monitoring (IONM) is widely used in the practice of spine surgery as a mean of preventing and reducing severe complications inherent to surgical techniques like paraparesis, paraplegia and quadriplegia. Indeed, a great deal of funding and work have been devoted to research projects seeking to determine the impact of IONM in reducing these risks. The results of such projects have been notoriously interesting, and frequently opposing to each other. This has lead to an open debate on weather the use of IONM may or not be justified by better outcomes in patients who undergo such procedure. To our knowledge there is no study in the literature that has addressed the potential role of the IOM to predict the long-term outcome of the patient in therms of radicular symptoms improvement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar spine surgery with IONM | – | –Patients diagnosed with 1 or 2 level lumbar disk disease and radicular symptoms who underwent decompressive surgery, and for whom IONM records exist. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lumbar disk disease with radiculopathy, undergoing neurological surgery of the spine at the ABC Neurological Center
Key inclusion criteria (3 listed)
- Diagnosis of Lumbar Disk Disease
- Clinical Signs of Radiculopathy
- Undergoing neurological surgery of the spine
Key exclusion criteria (3 listed)
- Previous neurological surgery of the lumbar spine
- More than 2 levels intervened at the surgery
- Serious post-operatory complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electrophysiological changes measured through intraoperative neurophysiological monitoring.
Time frame: Trans-operative
Standard register electrodes where placed from L1 to L5 myotomes and dermatomes. Through trans-operative real time modalities (trans-cranial electric motor evoked potentials, somatosensory evoked potentials, and spontaneous electromyography) measurements on amplitude and voltage were recorded at the beginning and at the end of the spinal decompression. This change will be studied to determine its predictive power in the clinical long-term outcome of the patients.
3 secondary outcomes
Visual analogue scale for pain
Time frame: In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Visual Analogue Scale for Pain
Oswestry Disability Index 2.1a
Time frame: In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Oswestry Disability Index 2.1a
Patient's Global Impression of Change Survey
Time frame: In the follow-up visits up to two years after the completion of the neurological surgery, the patient will be asked to complete the Patient's Global Impression of Change Survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Background: PubMed 24818737Koerner JD, Glaser J, Radcliff K. Which Variables Are Associated With Patient-reported Outcomes After Discectomy? Review of SPORT Disc Herniation Studies. Clin Orthop Relat Res. 2015 Jun;473(6):2000-6. doi: 10.1007/s11999-014-3671-1.
- Background: PubMed 24741132Sabnis AB, Diwan AD. The timing of surgery in lumbar disc prolapse: A systematic review. Indian J Orthop. 2014 Mar;48(2):127-35. doi: 10.4103/0019-5413.128740.
- Para mas informacion sobre hernias de disco, porfavor visite la siguiente pagina de internet:Link provided by the sponsor.
- For more information on disk hernias, please visit the following web page:Link provided by the sponsor.
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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.
Roberto De Leo Vargas, MD study director
American British Cowdray Medical Center
Maximino Tellez, MD study chair
American British Cowdray Medical Center
Ildefonso Muñoz Romero, MD study chair
American British Cowdray Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Disease, run by American British Cowdray Medical Center at 1 site in Mexico.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jul 2014. 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 Mexico. 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?
Results are not available in the source record.
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?
Electrophysiological changes measured through intraoperative neurophysiological monitoring. (time frame: Trans-operative). 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 NCT02185508, which also lists 2 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 9 Jul 2014.