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OSKA PEMF Pain Relief Device: A Mini Review Trial

PPM is pleased to launch a new technology column, offering clinical reviews of the latest pain management devices, mobile applications, and more. Here, the OSKA Pulse is tested at an outpatient chronic pain center in Michigan.
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About the Device

Product: OSKA Pulse, a pulsed electromagnetic field wearable device

Indication: This nonprescriptive, FDA-registered Medical Device Class 1 is manufacturer-
indicated for acute or persistent pain due to injury in the back, knee, muscles, and joints, or as a result of other pain-related conditions such as sciatica, plantar fasciitis, and carpal tunnel syndrome.

Application: The portable, self-managed device may be worn under or over clothing at the site of pain via velcro straps as a standalone or complement to physical therapy.
Specifications: 5.2” x 3.5” x 1.25”; 8 ounces

Price: $399.99

Manufacturer: OSKA Wellness, Carlsbad, CA

Noteworthy: Released in 2016, the OSKA Pulse received the 2017 Tech.Co Startup of the Year and has been successfully trialed among US Special Forces. View a double-blind study of the device.

Patient Sample & Trial Conditions

A mini trial was conducted at a free-standing outpatient chronic pain center in Ypsilanti, Michigan, where a multi-disciplinary approach is utilized to treat persistent pain. All participating subjects provided informed consent.

Patients (n = 26) tested the device over a period of five to six weeks. Participants exhibited with a range of conditions: low back pain conditions including degenerative disc disease, radiculopathy, facet syndrome, idiopathic low back pain, and spinal osteoarthritis; as well as cervical radiculopathy; whiplash; cervical spine osteoarthritis; facet joint fixation/subluxation; chondromalacia; osteoarthritis or arthrofibrosis of the knee; patellar subluxation syndrome; ankle sprain; plantar fasciitis; shoulder rotator-cuff syndrome; fibromyalgia; vasculitis; and chronic venous insufficiency.

The short-term trial included brief exposures to the device in the clinical setting, for approximately 30 minutes per day, twice a week. On average, patients used the device three to five times in total at the site of pain. Limited blinding was applied to those reporting pain relief. Testing also included effect on increased perfusion immediately post-treatment using an O2 biosensor at the capillary level.

Evaluation & Background

The device arrived in a very sleek package design, invoking in its presentation a sensation of pain relief. The evaluation team included on-site patient reports combined with the experiences of the clinic’s physical therapist, exercise physiologist, research coordinator, and massage therapist. Experience with the device was both pleasant and surprising in that our team was not expecting such an inexpensive made-for-the-home device to find a place in a “cutting edge” pain clinic, where practitioners take pride in the wide array of conservative (and some expensive) options for treating chronic musculoskeletal pain.

The device was deemed not only cost-effective, but also promising in its ability to provide clinical quality pain relief for select patients. The OSKA Pulse emits very low-level pulsed electromagnetic field (PEMF) energy. The evaluating team’s practice carries two clinical-grade PEMF device technologies that are much more expensive and deliver more energy per unit time, but as demonstrated in this mini trial, less energy is not necessarily less effective. Although our mini trial was not intended to be a comparative effectiveness study, we could not help being curious about the level of pain relief provided by the different PEMF devices. Our team’s primary goal, however, was to test the device in a controlled environment with as many clinical conditions as possible.

Results

The device performed better than expected for such a small and inexpensive therapy. As with any new treatment, part of our evaluation was to identify those patients who responded the strongest to the treatment and use this subpopulation as the study group. We then obtained informed consent and used a single-blind approach to also deliver sham treatments. As noted, our patient sample presented with a variety of aches and pains—some standalone, others part of a more complicated syndrome likely influenced by comorbidities and medication intake—both factors we could not control.

For those patients known to be strong responders, we tested a placebo effect by informing them that we would, on occasion, turn off the device without their knowledge. As a result, some treatments were real, and others were not, but all patients consented to the methods. The device fared well under this approach, with responders correctly identifying the false treatments most of the time (70%).

Regarding perfusion, we found an approximate 4% increase in oxygen saturation levels after a single 30-minute exposure to the device. However, the sample size was too small to draw a statistical conclusion on this measure.

Noted limitations of the device necessitated multiple 30-minute applications throughout the day to achieve the desired level of pain relief. When pain relief was achieved, it lasted a few hours, which aligns with typical clinical practice pain relief. This inherent factor, however, might be enough to dissuade some patients from using the device and/or reaping its full benefit. It is noted that the manufacturer website calls for the device to be used four to six times per day (30 minutes per application) for the first week to treat long-term injury or pain, reducing applications to two to four times per week after 90 days of use, and patients are advised to drink plenty of water to maximize benefits.

The rigid manufacture of the device’s current design limits comfortable placement of the device in some locations. Our knee patella-femoral patients, for example, who needed the exposure anterior-posterior would best be served with a more flexible application allowing contouring over the desired area.

Recommendation

Overall, the OSKA Pulse performed quite well in a clinical setting among some formidable competition. In the home setting, the device is well worth suggesting trial for those suffering from musculoskeletal pain conditions and who desire cost-effective, self-managed pain care. Our practice intends to keep the device in mind as a suitable home pain management treatment, especially for those patients deemed unresponsive to transcutaneous electrical nerve stimulation applications.

Last updated on: March 14, 2018
Continue Reading:
Treating Chronic Pain Using the Oska Pulse Device
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