Objective To create a questionnaire that can identify patients who will respond well to high-frequency spinal cord stimulation.
Materials and Methods Thirty-three patients who received permanent implantation of a high-frequency spinal cord stimulator were followed for up to one year. Preoperative patient data in the form of a packet containing pain metrics, the Douleur Neuropathique 4 (DN4) questionnaire, and a questionnaire thought to contain clinically useful questions were collected. Visual analog scale (VAS), Oswestry Disability Index (ODI), and subjective overall percent pain reduction were collected at time points of 6 weeks, 3 months, 6 months, and 12 months.
Results Patients who revealed that they could walk before a long period of time before their pain worsened, whose pain was consistent throughout the day, whose pain wakes them up from sleep and whose pain is worse when leaning side to side had a significant increase in ODI following SCS. Additionally, patients who reported only being able to sit or lie down for less than thirty minutes before having to move experienced significantly decreased ODI.
Conclusions While literature has shown that patients with neuropathic pain respond to SCS, identifying which patients clinically would have an optimal response remains a challenge. Future studies on a greater number of patients are needed to further develop a questionnaire to better identify clinical signs consistent with low back pain that will respond to spinal cord stimulation.
Sources of Financial Support Financial support for this project was provided by Nevro
Conflict of Interests Dr. Ashwini Sharan reports personal fees from Neuspera, personal fees from Medtronic, grants and personal fees from Dixi, personal fees and other from Cerebral Therapeutics, outside the submitted work. Dr. Chengyuan Wu reports grants from Nevro, during the conduct of the study; personal fees from Nevro, personal fees from Abbott, personal fees from Medtronic, personal fees from Boston Scientific, personal fees from MicroSystems Engineering, outside the submitted work.
Competing Interest StatementDr. Ashwini Sharan reports personal fees from Neuspera, personal fees from Medtronic, grants and personal fees from Dixi, personal fees and other from Cerebral Therapeutics, outside the submitted work. Dr. Chengyuan Wu reports grants from Nevro, during the conduct of the study; personal fees from Nevro, personal fees from Abbott, personal fees from Medtronic, personal fees from Boston Scientific, personal fees from MicroSystems Engineering, outside the submitted work.
Funding StatementFinancial support for this project was provided by Nevro
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Thomas Jefferson University Institutional Review Board
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Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present work are contained in the manuscript
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