Abstract
As COVID-19 rampages throughout the world and has a major impact on the healthcare system, non-emergency medical procedures have nearly come to a halt due to appropriate resource reallocation. However, pain never stops, particularly for patients with chronic intractable pain and implanted spinal cord stimulation (SCS) devices. The isolation required to fight this pandemic makes it impossible for such patients to adjust the parameters or configuration of the device on site. Although telemedicine has shown a great effect in many healthcare scenarios, there have been fewer applications of such technology focusing on the interaction with implanted devices. Here, we introduce the first remote and wireless programming system that enables healthcare providers to perform video-based real-time programming and palliative medicine for pain patients with a SCS implant. During the COVID-19 pandemic from January 23, 2020, the date of lockdown of Wuhan, to April 30, 2020, 34 sessions of remote programming were conducted with 16 patients. Thirteen of the 16 patients required programming for parameter optimization. Improvement was achieved with programming adjustment in 12 of 13 (92.3%) cases. Eleven of the 16 (68.8%) patients reported that the system was user-friendly and met their needs. Five patients complained of an unstable connection resulting from the low network speed initially, and three of these patients solved this problem. In summary, we demonstrated that a remote wireless programming system can deliver safe and effective programming operations of implantable SCS device, thereby providing palliative care of value to the most vulnerable chronic pain patients during a pandemic.Clinical Trial Registrationwww.clinicaltrials.gov, identifier NCT 03858790.
Highlights
The world has changed rapidly due to the disastrous Coronavirus Disease 2019 (COVID-19) pandemic
The exclusion criteria were the following: (1) pregnancy, breast feeding, plan to be pregnant or unwilling to use contraceptive methods; (2) bleeding complications or coagulation disorders; (3) severe mental or cognitive disorders, leading to inability to cooperate during surgery and postoperative programming; (4) life expectancy of less than oneyear; (5) need for therapy or examination that could not be provided with an implanted pulse generator (IPG), such as magnetic resonance imaging and thermo-therapy; and (6) other inappropriate situations that were determined by the investigators
With regard to neuromodulation therapies, such as spinal cord stimulation (SCS), deep brain stimulation (DBS), vagal nerve stimulation, and sacral nerve neuromodulation, implantation of the device is only the first step, and post-operative programming is important for achieving long-term curative effect
Summary
The world has changed rapidly due to the disastrous Coronavirus Disease 2019 (COVID-19) pandemic. Governments and medical providers have had to reallocate labor and material resources to deal with this abrupt emergency. Patients are avoiding visiting medical facilities that may be considered a potential source of infection (Keesara et al, 2020). For patients with demands that cannot be delayed and are impossible to fulfill with the medical resources on site because of isolation protocols or resource limitations, telemedicine has offered an alternative solution (Keesara et al, 2020). The smartphone and the external programmer-activated IPG were paired. According to the patients’ requests or previously stated reservation, the healthcare provider logged into the programming system and established the connection with the patient’s smartphone after activation of the IPG with patient’s external programmer. The IPG could work with the physician’s instructions (Figure 1A)
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