Chronic pain is one of the greatest healthcare problems facing the U.S. and other nations. It is also a burgeoning market opportunity for neuromodulation device vendors. Although historically, neurotech therapies have played a major role in treating chronic back pain, as Jennifer French points out in her article on page 1 of this issue, migraine pain is rapidly emerging as a new market opportunity. And unlike the situation with the spinal cord stimulation device industry, the market for occipital nerve stimulation and related therapies is not dominated by a small number of large companies. Indeed, the market is something of a wild west right now, with startups and established players alike trying to gain a foothold.
Many of the clinical issues pain doctors confront in dealing with chronic pain were discussed at the Napa Pain Conference earlier this month [see conference report, p7]. Chief among these are opioid abuse, psychological problems, job dissatisfaction, unreasonable patient expectations, and legal conflicts. Pain doctors thus have the unenviable task of trying to cure a disease that is just not curable in many individuals. This situation not only leads to patient dissatisfaction, but it also potentially poisons clinical trials for non-opioid pain therapies that would otherwise be successful.
For these reasons, it is clearly in the interest of all involved parties—patients, doctors, pharmaceutical and device vendors, payers, and employers—to develop an objective measure of pain. Just as the National Institute of Mental Health has argued for a transition away from subjective diagnoses for psychiatric disorders and toward objective biomarkers, we would like to see NINDS, the FDA, and other government agencies move away from dependence on subjective pain measures like visual analog scores and toward more objective measures of pain.
The Israeli firm Medasense has made considerable progress with its PMD-200 device and Nociception Level Index, initially in operating room settings [NBR Jun15 p7]. The technology combines a noninvasive finger probe incorporating four sensors: photoplethysmograph, galvanic skin response, temperature, and accelerometer. Saluda Medical and other firms pursuing closed-loop neuromodulation are also making progress in this direction. But more is needed, including a reliable and affordable diagnostic for use in doctors’ offices and clinics.
The worldwide opioid epidemic has drawn attention to the problems posed by chronic pain and also the consequences when clinicians, vendors, and payers cling too closely to one therapeutic approach at the expense of others. Hopefully, the neuromodulation industry will chart a more viable course through these troubled waters.
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