New wearable prevents and reduces chronic low back pain dysfunction, study finds
In a randomized clinical trial published this week in Frontiers in Pain Research, a novel wearable device significantly outperformed electrical stimulation in restoring function and preventing chronic pain among adults with moderate-to-severe low back pain. Compared to electrical stim, adding DuoTherm vibratory mechanical stim to routine care for 30 minutes daily showed:
3x more complete restoration of function: 23.9% of high-severity DuoTherm users had zero chronic pain disability at 6 months compared to 7.1% using TENS (p=0.04)
2.5x more effective in >30BMI subjects: after 6 months of use, DuoTherm improved PROMIS pain interference (disability) more than one standard deviation (-13) in those meeting the definition of obesity. TENS difference was not clinically relevant (-5.2) (p=.01)
Prevented chronic pain >2x more: At 3 months, acute low back pain resolved for 68.2% using DuoTherm, compared to 27.3% using TENS (p=0.015)
ATLANTA, GA — August 18, 2025 — Low back pain affects 60% of Americans annually and contributes more than $200 billion to healthcare costs. A study this week in Frontiers in Pain Research offers hope, as a novel wearable both prevented and restored function for the most severe patients with chronic pain.
“Injuries, degenerative disease, and posture can all cause spinal muscle dysfunction and pain,” explained Amy Baxter MD, lead investigator and clinical Professor at Augusta University.
“We knew vibration, pressure, thermal therapies, and options all had good theoretical support for both pain and repair, so we tried combining them into one device.”
The DuoTherm device distributed harmonic interactions of multiple specific frequency patterns and temperature through a metal low back plate. Chiropractic patients with moderate-to-severe chronic low back pain (115) were randomized to add either DuoTherm or a transcutaneous electrical nerve stimulator (TENS) for 30 minutes to any other therapies. Over 6 months, DuoTherm users had faster and greater improvement in pain and functional disability than those randomized to TENS (Linear Mixed Model p=.002 (pain) to .024(PROMIS Pain Interference)).
DuoTherm’s benefits were most significant in the most extreme subsets of patients. Those with pain for more than five years had significantly improved pain interference scores by week ten. With higher severity, over three times more DuoTherm users reached zero disability than TENS. Notably, the noninvasive device significantly reversed disability in patients with high BMI, for whom surgery is often not an option.
Outpatient acute pain often comes from a motor vehicle collision or a pulled muscle. Back injuries on the job are common: in 2022, 67,500 workers averaged $40,000 in back injury costs. While most acute low back pain resolves within weeks, 40% progress to chronic, risking long-term disability and opioid dependence. For 44 subjects with acute low back pain, DuoTherm altered that trajectory. Compared to an electrical stimulation device (TENS), at three months, two times more DuoTherm users returned to normal low back function, and more than three times reached zero disability.
"Preventing pain from becoming chronic was unexpected," said Dr. Amy Baxter. "Previously, exercise and physical therapy worked best, so the device may mimic or encourage movement.”
As chronic low back pain causes the most years lived with disability worldwide, these results could mark a turning point.
“If we can prevent just a fraction of patients from developing chronic pain, the ripple effect on public health and healthcare costs would be enormous,” Baxter said.
The study was funded by the National Institute on Drug Abuse as a part of the NIH HEAL Initiative. The primary intent of the study was to reduce opioid prescribing when patients presented with acute pain. Noninvasive, multimodal solutions like DuoTherm are recommended as first line by guidelines, but Medicaid and Medicare only cover opioids. Multimodal DuoTherm was designed to speed emergency discharge without prescribing. The study, published in July, found no opioid-naive patients received a prescription, and DuoTherm significantly reduced prescribing compared to national rates while TENS did not. The study can be found here.
Media Contact: Cate Crutcher, Harmonic Scientific, CCrutcher@HarmonicScientific.com, +1 877-805-2899
Study Registration: ClinicalTrials.gov NCT04494698
Funding: National Institutes of Health HEAL Grants R44DA049631 and R44DA058952