Novel Back Pain Wearable: An Opioid Alternative
Highlights:
Low back pain is the leading cause of outpatient opioid prescribing.
1 in 20 prescribed opioids develop opioid use disorder.
An NIH-funded trial compared a novel multimodal wearable to TENS. The new device:
Eliminated prescribing in opioid-naive subjects.
Lowered the daily risk of taking an opioid 9x times for those who did use (7.5 mg morphine vs. 498.5 mg, p < 0.0001)
Reduced low back pain prescribing 63% compared to the national average (9.8% vs. 25%, p=.002).
Among those using opioids, DuoTherm™ reduced use by 44.6% in the first month.
Atlanta, GA – July 10, 2025 — A landmark randomized controlled trial funded by the National Institutes of Health found that a multimodal mechanical stimulation (M-Stim®) device, DuoTherm™, prevented new opioid prescribing and reduced opioid use in patients seeking treatment for moderate-to-severe low back pain. The peer-reviewed paper marks a pivotal moment in the fight against the opioid epidemic.
“Pain is overwhelming. Studies show combining temperature, pressure, and vibration improves coping and reduces pain. We also included frequencies shown to improve movement and blood flow, aiming to not only improve self-efficacy but also recovery,” noted Dr. Amy Baxter, lead investigator and CEO of Harmonic Scientific LLC.
Of 159 patients with non-radiating low back pain randomized to DuoTherm™ or a TENS unit, zero opioid-naive patients using M-Stim were prescribed opioids compared to 9% in the TENS group. For those taking any opioids, the device significantly reduced opioid use days and quantity, (p<.0001) two factors associated with prolonged opioid use and disorder.
The DuoTherm™ group also showed a 63% lower prescribing rate than the national average for similar pain cases (9.8% vs. 25%, p=.002). Among those already using opioids, DuoTherm™ reduced use by 44.6%.
“These results are game-changing,” said Baxter. “Low back pain treatment guidelines recommend multiple modalities, but unfamiliar or busy doctors prescribe opioids to 25%. For the first time, we’ve shown a wearable multimodal device could eliminate opioid prescribing for acute low back pain.”
As low back pain is the leading reason for outpatient opioid prescribing and a gateway to opioid use disorder in 1 out of 20 cases, these findings have substantial implications for public health. DuoTherm™ will be evaluated as a new therapy by the FDA and is expected to be available for prescription in 2026. You can preorder DuoTherm™ devices here: harmonicscientific.com/waitlist
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Media Contact:
CCrutcher@HarmonicScientific.com
(404) 798-8272
Study Registration:
ClinicalTrials.gov NCT04491175
Funding:
National Institutes of Health HEAL Grant R44DA049631
National Institutes of Health HEAL Grant R44DA058952
