Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.

Lumbar Disc Disease Clinical Trial

Official title:

Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Radiculopathy Associated to Lumbar Disk Disease. Two Years Follow-up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02185508
• Other study ID #: ABC-14-06
• Status: Active, not recruiting
• Phase: N/A
• First received: July 4, 2014
• Last updated: July 4, 2014
• Start date: January 2011
• Est. completion date: August 2014

Study information

• Verified date: July 2014
• Source: American British Cowdray Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Lumbar Disc Disease
• Radiculopathy

Locations

Country	Name	City	State
Mexico	American British Cowdray Medical Center	Mexico City	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
American British Cowdray Medical Center

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General demographic, personal and biometrical data	The survey used to capture general demographic, personal and biometrical data is designed according to the stipulations of the Official Mexican Norm for the Clinical Record (NOM-004-SSA3-2012). The data obtained through such survey will help the surgeon in assessing the case of the patient. Some or all of this data may be used for analysis in this study, to be compared with the rest of the outcome measures. A privacy policy statement may be provided to the patient according to the Federal Law for the Protection of Personal Data in Possession of Particulars (Ley Federal de Protección de Datos Personales en Posesión de los Particulares). Regardless of such formality, the privacy of the patient will be assured throughout the study.	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	No
Primary	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.	Trans-operative	No
Secondary	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	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	No
Secondary	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.	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	No
Secondary	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.	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	No

External Links

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