Device shows promise for treating low back pain and reducing opioid use disorder

This article was originally published by The National Institutes of Health. You can read it here.

Low back pain affects 80% of Americans during their lifetimes and is the most disabling condition worldwide. Up to 50% of cases of moderate-to-severe acute low back pain will become chronic. It is also the most common reason for outpatient opioid prescribing.

Current evidence-based guidelines for treating low back pain recommend several types of therapies, including cold, heat, exercise, and transcutaneous electrical nerve stimulation (TENS), but in the U.S., doctors often prescribe opioids as a first treatment. In a pilot study, a device developed with support from NIH that provides heat, pressure, and harmonic multifrequency vibration, called an M-Stim device, was found to reduce both acute and chronic low back pain. Following this, a research team conducted an NIH-supported randomized controlled clinical trial to compare M-Stim to TENS, when these treatments are added to other therapies. Findings from this trial were recently published in two different papers in the journal Frontiers in Pain Research.

In the clinical trial, 159 people with moderate-to-severe low back pain were randomly assigned to either M-Stim or TENS for 30 minutes daily in addition to other therapies. Pain, opioid use, and device use were reported daily for 28 days, and weekly for up to six months.

Findings in the first study showed that among participants who were “opioid-naïve,” or had not previously used opioids for back pain, the use of the M-Stim device significantly reduced risk factors associated with opioid use disorder compared with TENS. Zero “opioid-naïve” M-Stim participants received opioid prescriptions, and those taking opioids used significantly fewer. In those taking opioids whose body mass index (BMI) was 30 or greater, M-Stim reduced the number of days of opioid use.

In the second study, the researchers found that M-Stim improved pain and disability for both acute and chronic low back pain and reduced progression from acute to chronic low back pain more than TENS. Both devices reduced pain initially, but M-Stim reduced pain and disability significantly more over time, especially in people with chronic low back pain with higher severity, duration, or BMI.

The findings suggest that such a device, which uses a combination of stimulation modes, could potentially be helpful in treating low back pain and reducing risk factors for opioid use disorder and overdose.

The research was funded by the NIH National Institute on Drug Abuse as part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®.