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

NCT02185508 | Unknown

• 1 other identifier: ABC-14-06
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Disc Disease

Keywords

IONM; Lumbar Disk Disease; Degenerative Spine Disease; Radiculopathy; Intraoperative Neurophysiological Monitoring; Somatosensory Evoked Potentials; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Visual analogue scale for pain

  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

  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

  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 (1)

• General demographic, personal and biometrical data

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• American British Cowdray Medical Center: lead

Study Sites (1)

American British Cowdray Medical Center

Mexico City, Mexico City, 05300, Mexico

Location

Related 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.

  PMID: 24818737 BACKGROUND

• 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.

  PMID: 24741132 BACKGROUND

Related Links

• Para mas informacion sobre hernias de disco, porfavor visite la siguiente pagina de internet:
• For more information on disk hernias, please visit the following web page:

MeSH Terms

Conditions

Intervertebral disc disease; Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Roberto De Leo Vargas, MD

  American British Cowdray Medical Center

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• Eduardo Galvan Hernandez, MD

  American British Cowdray Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 9, 2014
• Study Start: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

ME (1)