Can Medical Devices Replace Painkillers?

Chronic pain affects more Americans than cancer, heart disease and diabetes combined. Understand what's on the current landscape for pain management and where Frost & Sullivan expects emerging therapies to develop.

Much like pain itself, the impact of pain in today’s society cannot be easily described. A physician resorts to a combination of indicators from the patient and a standardized pain scale to comprehend suffering; market researchers have to resort to studying the statistics surrounding pain. The U.S. National Academy of Sciences (NAS) estimates that more than 100 million Americans suffer from chronic pain—the kind that lasts for more than 3 months. It affects more Americans than cancer, heart disease and diabetes combined. According to the NAS, the direct medical costs associated with chronic pain management exceed $500 billion annually. This does not factor in indirect costs associated with loss of productivity and sick days, which total another $100 billion. 

Managing pain is a complex task, not least because the therapy depends on the underlying condition. However, patients often use painkillers without understanding the complexity of the pain and the condition causing it. Over the years, painkiller use—and abuse—has increased tremendously.  The U.S. Centers for Disease Control and Prevention report that the sale of prescription opioid painkillers quadrupled between 1994 and 2014, while noting that the overall amount of pain that Americans report had not increased. During this period, more than 165,000 people died due to painkiller abuse. All these statistics point to the need for non-drug pain management solutions. 

Frost & Sullivan has identified a few exciting companies that have developed devices to manage chronic and acute pain. While there are several non-drug pain management therapies, including physiotherapy and acupuncture, the focus here is on cutting-edge medical technologies that could replace pharmaceutical drugs.

Quell from NeuroMetrix, Inc. (Waltham, Mass.)

NeuroMetrix developed a line of wearable devices, most notably Quell and Sensus, that  provide relief to patients suffering from chronic pain. Both are drug-free solutions that act by modulating the nerves that cause the pain sensation. 

Quell uses a proprietary technology called Wearable Intense Nerve Stimulation (WINS). An electrode-sensor combination is packaged as a device that is worn below the knee or looped as a belt around the waist. The electrode produces mild electrical impulses that activate the sensory nerve endings that cause pain in various muscles. The nerves then pass the signals to the brain, triggering a pain relief response that alleviates it locally. Interestingly, Quell can gauge the level and intensity of pain that the person is experiencing and adjust its stimulation accordingly. It is cleared to treat a wide range of chronic pain conditions, but specifically painful diabetic neuropathy, fibromyalgia, sciatica, osteoarthritis and lower back problems.

Sensus uses a well-established technology known as transcutaneous electrical nerve stimulation (TENS). As the name suggests, it uses mild electrical pulses to stimulate the peripheral nerves through the skin. Unlike Quell, the intensity of current and other parameters must be set by the physician prescribing the device. 

Cefaly from Roxon medi-tech (Ontario, Canada)

Roxon medi-tech developed a wearable pain-relief device known as Cefaly. The lightweight and portable device is worn like a headband. Cefaly is the first—and one of only a few—U.S. Food and Drug Administration (FDA)-cleared medical devices for the treatment of migraines and cluster headaches. Like Sensus, Cefaly uses TENS technology to send mild electrical impulses to the trigeminal nerve, which is responsible for sensations such as pain, pressure and temperature in the cranium.  These pulses are experienced by the patient as a mild massage at the center of the forehead. 

The stimulation triggers the trigeminal nerve to produce endorphins, which is an inhibitory opioid neurotransmitter molecule. By activating the nerve and flooding the trigeminal region with endorphins, the nerves do not have the bandwidth to transmit to one another the pain sensation that results in migraines. In other words, the endorphins competitively inhibit the pain indicators from being the primary sensation in the trigeminal region.

COOLIEF from Halyard Health (Alpharetta, Ga.)

COOLIEF, Halyard’s innovative offering for the effective management of chronic pain, uses a cooled radiofrequency (RF) platform to target the sensory nerves that cause pain. COOLIEF is a non-surgical and non-narcotic outpatient procedure. During the treatment process, water is circulated through the device to ensure that it is not heated; the heat instead is dispersed to the tissue. The RF lesion created by heating the nervous tissue is larger than in conventional RF treatments and enhances pain relief.

The company’s product portfolio covers cooled RF-based treatment solutions for chronic pain arising in hip joints, lumbar zygapophysial joints, lower back, sacroiliac joints, osteoarthritic knees, cervix and thoracic facet joints. In April 2017, the FDA cleared COOLIEF for the management of chronic knee pain that arises due to osteoarthritis.

Quadrabloc from Gradient Medical (Memphis, Tenn.)

Quadrabloc uses patented quadra-polar magnetic discs couched in a soft strap that is worn around the waist, elbow, neck or knee. Unlike other magnetic therapies on the market that use a single, powerful neuromagnetic disc, each Quadrabloc disc uses four. Three or more of the discs are arranged in a grid or an array to optimize the magnetic field that is generated. The compounded effect of these magnetic discs blocks the pain signals that originate from localized sensory nerves. In effect, the device reduces the firing rate of the pain signals and suppresses the inflammatory response to pain. 

Quadrabloc received FDA clearance in March 2017, and it is available as an over-the-counter pain management device.

The Road Ahead

Wearable devices are the flavor of the decade. Frost & Sullivan expects that more therapies—ultrasound, electrical stimulation and heat therapy—will be packaged as wearable devices. Another market darling, the mobile app, is also expected to play an important role in pain management. Already, Quell has an accompanying app that can calibrate the device, analyze the user’s sleep and activity patterns, and help set therapy cycles. Apps are expected to play a more important role in providing insights related to pain and pain sensation, helping physicians refine the therapy, lest the next generation fall prey to electrical stimulation addiction like this generation became hooked on prescription medication. 

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