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

July 4, 2014 updated by: Galvan Ernesto Eduardo, American British Cowdray Medical Center

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:

  • 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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 05300
        • American British Cowdray Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Trans-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General demographic, personal and biometrical data
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American British Cowdray Medical Center

Investigators

  • Study Director: Roberto De Leo Vargas, MD, American British Cowdray Medical Center
  • Study Chair: Maximino Tellez, MD, American British Cowdray Medical Center
  • Study Chair: Ildefonso Muñoz Romero, MD, American British Cowdray Medical Center
  • Study Chair: Miguel Angel Collado Corona, MD, American British Cowdray Medical Center
  • Study Chair: Leopoldo Torres Vyera, MD, American British Cowdray Medical Center
  • Study Chair: Christian Cerecedo, MD, American British Cowdray Medical Center
  • Principal Investigator: Eduardo Galvan Hernandez, MD, American British Cowdray Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 4, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC-14-06

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.

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