Purdue Pharma and Geisinger announced today that the first patient has been enrolled in the companies’ upcoming trial of medical wearables as an alternative therapy for chronic pain.
The ResearchKit study looks to see how wearables (in this case, the Apple Watch) can alleviate pain without relying on pharmaceutical painkillers, a commendable goal for a company whose painkilling opioid OxyContin has been at the heart of the US’ ongoing opioid epidemic.
“What we are really looking at is whether we can we decrease pain, improve functioning, and reduce reliance on pain medication,” Dr. Tracy Mayne, Purdue’s head of medical affairs strategic research, told MobiHealthNews in March. “They aren’t all necessarily ... taking opioids, but these are very sick patients with chronic pain and a lot of comorbidities, and I would be very surprised if even some of them haven’t been on pain medication for a long time.”
In the non-randomized prospective trial, 240 adult multidisciplinary pain-program patients receiving treatment within the Geisinger healthcare system will receive an Apple Watch to measure physical activity, self-reported pain, heart rate, medication use, and other relevant variables over 12 months. The watches will be outfitted with a specialized pain app and healthcare provider dashboard that not only integrates with Geisinger’s EMR, but suggests alternative pain treatment strategies such as stretching, mindfulness, and thermotherapy.
“The goal of this technology is to improve patient function and quality of life while reducing the need for analgesic medications. It provides objective measures of numerous aspects of pain, function, and treatment effectiveness so that information can be gathered for the patient and the healthcare provider in between visits,” Dr. Tracy Mayne, head of medical affairs strategic research for Purdue Pharma, said in a statement. “We are pleased to partner with Geisinger on this important initiative and believe real-time data may have the potential to support an improved understanding of chronic pain patients’ experiences and needs.”
Purdue Pharma and Geisinger also plan to enroll 240 multidisciplinary pain patients as controls within the same 12-month period, in addition to a historic control group of 150 patients who previously completed the standard pain program. The study’s clinical endpoints include pain scores, medical depression scores, pain medicine use, and changes in physical function or disability over time. Researchers will also assess secondary study aims related to potential improvements in sleep, activity level, and daily pain scores resulting from the smartwatch-based program.
“The proposed multi-level integrated platform will facilitate and accelerate the speed of communication between the patient and healthcare providers, thereby allowing quicker patient access to appropriate care,” Dr. John J. Han, director of the Department of Pain Medicine at Geisinger, said in a statement. “Furthermore, it is hoped providing more education as well as alternative, non-opioid treatment options and coaching to promote a long-term sustainable healthy lifestyle will improve patient function and quality of life.”
As the most prominent smartwatch in the industry, Apple’s wearable has been front and center among the growing number of medical studies relying on wearables. Outside of the company’s own investigation of arrhythmias, startup Cariogram found in its mRhythm Study that an atrial fibrillation-detecting algorithm using the Apple Watch’s sensors could detect the irregularities with 97 percent accuracy. In February, Takeda Pharmaceuticals and Cognition Kit also announced that they would be collaborating on an Apple Watched-based depression study.