New nerve check during back surgery could prevent damage
NCT ID NCT02272140
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a method to monitor nerve health during a specific type of spine surgery called XLIF. Researchers used mild electrical stimulation on the lower back nerves during surgery and checked if changes in nerve signals could predict nerve problems after surgery. 324 adults with degenerative disc disease took part. The goal was to see if this monitoring technique can help surgeons avoid nerve injury.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous electrical nerve stimulation
- What this could lead to
- If successful, this technique could help surgeons monitor nerve health during spine surgery and reduce the risk of nerve damage.
- What could go wrong
- This is an observational study, not a treatment trial. The technique may not reliably predict nerve injury, and results may not apply to all spine surgeries.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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324 people
The number who actually took part.
- Started
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Jul 2014
- Finished
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Oct 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who, in the investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female spine surgery patients who are at least 18 years of age; 2. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier; 3. Surgical candidates for extreme lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5; 4. Able to undergo surgery based on physical exam, medical history and surgeon judgment; 5. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation. Exclusion Criteria: 1. Patient has a mental or physical condition that would limit the ability to comply with study requirements; 2. Currently undergoing any surgical treatment at any spinal level other than L2 to L5; 3. Currently undergoing surgical treatment for significant deformity correction (e.g., osteotomy, anterior longitudinal ligament release, or other significant manipulation of the spinal column); 4. Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy); 5. Implanted pacemaker, defibrillator, or other electronic devices; 6. Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested); 7. Pregnant women; 8. Patient is a prisoner; 9. Patient is participating in another clinical study that would confound study data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Columbia Orthopedic Group Research
Columbia, Missouri, 65201, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, 33637, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, 99208, United States
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Piedmont Healthcare
Atlanta, Georgia, 30309, United States
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Scripps Clinical Research Services
La Jolla, California, 92037, United States
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Seton Brain and Spine Institute
Austin, Texas, 78701, United States
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USF Neurology and Neurosurgery
Tampa, Florida, 33606, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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West Augusta Spine Specialists, LLC
Augusta, Georgia, 30909, United States
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Western Regional Center for Brain & Spine Surgery
Las Vegas, Nevada, 89109, United States
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