• Pain left untreated can have physical, psychological, social, and economic consequences
• Financial burdens of untreated chronic pain (such as absenteeism, income loss, healthcare costs, and workers compensation) place the same strain on countries as cancer and cardiovascular disease
• Neuromodulation has been proven effective for the treatment of pain
• Determining a good candidate for neuromodulation can be a challenge
• Combining neuromodulation with wearable technology can be leveraged to improve patient care and selection
• MAIN System improves resource allocation, patient selection, efficacy, safety, and outcomes.
The cost of chronic pain has been estimated to be as high as $635 billion in the United States alone. Pain is the most common reason patients seek medical care. Millions of people in the United States are living with untreated pain. They often are marginalized or ignored while others are not interested in pharmacological or traditional treatment measures.
The use of spinal cord stimulation and neuromodulation has proven efficacy for the treatment of a multitude of pain conditions including lumbar radiculopathy and failed back surgery. However, there is significant evidence that neuromodulation works for a variety of pathological processes. Unfortunately, this patient population is often not provided with a trial of neuromodulation, because of poor objective data and lack of reported outcomes. Furthermore, neuromodulation provides a method for reduction in opiate use, tolerance, and abuse.
Before the implant of a definitive neuromodulation device, a patient must undergo a trial where the leads are placed percutaneously into the epidural space. The patient is then sent home with an external controller and a battery pack for a of total 3-7 days. After the completion of the trial, the leads are removed. The patient's candidacy is typically determined by a reduction in their pain scores. If the patient has greater than 50% reduction in pain, they are then typically implanted with a permanent neuromodulation device.
While the visual analog system has been the standard for quantifying pain there is a need for more objective and quantitative measures. Functional status, return to work, ability to perform activities of daily life, and community involvement are likely better indicators of true function.
We suggest the first use of combined wearable technology and neuromodulation with the goal of expanding patient access to the technology, improved patient selection, and improved outcomes.
We propose a scenario in which patients would receive wearable technology prior to the date of spinal cord stimulator trial. During this period, the patient's activity and sleep quantity and quality would be monitored through the use of an accelerometer and heart rate monitoring. Pain score would be captured five times daily through prompts to the patient. Patient would also have the ability to document the time and frequency of breakthrough medication use. The patient would continue to wear this device through the neuromodulaton trial. The data obtained from the device would objectify the improvements in function from the trial. The use of the MAIN System would improve patient selection for neuromodulaton implants and not expose poor candidates to unnecessary risks.
Once the patient undergoes a definitive implant, we would look to collect data on when patients are obtaining the highest levels of pain and relief throughout the day. We in turn, would use this data to setup adaptive device settings that would provide specific stimulation such as burst and high frequency. This would be determined based on a previous pain level at specific times of the day, types of activity, or durations of activity.
The implementation of the MAIN system will allow for improved utilization of resources; as well as, improved patient safety, outcomes, and access to care.
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