Clinical trial NCT02185508: Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.
Official title: Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Radiculopathy Associated to Lumbar Disk Disease. Two Years Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Disc Disease
Keywords: IONM
Lumbar Disk Disease
Degenerative Spine Disease
Radiculopathy
Intraoperative Neurophysiological Monitoring
Somatosensory Evoked Potentials
Electromyography
Lead sponsor: American British Cowdray Medical Center
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with lumbar disk disease with radiculopathy, undergoing neurological surgery of the spine at the ABC Neurological Center

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Lumbar Disk Disease
* Clinical Signs of Radiculopathy
* Undergoing neurological surgery of the spine

Exclusion Criteria:

* Previous neurological surgery of the lumbar spine
* More than 2 levels intervened at the surgery
* Serious post-operatory complications

Primary outcomes:
measure: Electrophysiological changes measured through intraoperative neurophysiological monitoring.
timeFrame: Trans-operative
Secondary outcomes:
measure: Visual analogue scale for pain
timeFrame: 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
measure: Oswestry Disability Index 2.1a
timeFrame: 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
measure: Patient's Global Impression of Change Survey
timeFrame: 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
Other outcomes:
measure: General demographic, personal and biometrical data
timeFrame: In the pre-operatory consult with the surgeon, the patient will be asked to complete a survey enquiring about general demographic, personal and biometrical data
Locations:
city: Mexico City
country: Mexico
facility: American British Cowdray Medical Center
state: Distrito Federal
Study officials:
affiliation: American British Cowdray Medical Center
name: Roberto De Leo Vargas, MD
role: STUDY_DIRECTOR
affiliation: American British Cowdray Medical Center
name: Maximino Tellez, MD
role: STUDY_CHAIR
affiliation: American British Cowdray Medical Center
name: Ildefonso Muñoz Romero, MD
role: STUDY_CHAIR
affiliation: American British Cowdray Medical Center
name: Miguel Angel Collado Corona, MD
role: STUDY_CHAIR
affiliation: American British Cowdray Medical Center
name: Leopoldo Torres Vyera, MD
role: STUDY_CHAIR
affiliation: American British Cowdray Medical Center
name: Christian Cerecedo, MD
role: STUDY_CHAIR
affiliation: American British Cowdray Medical Center
name: Eduardo Galvan Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sabnis 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.