CLINICAL TRIAL article
Front. Pain Res.
Sec. Non-Pharmacological Treatment of Pain
Volume 6 - 2025 | doi: 10.3389/fpain.2025.1612572
Preventing Opioid Prescribing Using Multimodal Mechanical Stimulation vs. TENS for Low Back Pain: A Randomized Controlled Trial
Provisionally accepted
Amy Lynn Baxter1,2*
Jena Etnoyer-Slaski3Jessica Allia Rice Williams4Kevin Swartout5Lindsey L Cohen5M Louise Lawson6- 1Augusta University, Augusta, United States
- 2Harmonic Scientific LLC, Atlanta, GA, United States
- 3Kaizo Clinical Research Institute, Landover, MD, United States
- 4The Pennsylvania State University (PSU), University Park, Pennsylvania, United States
- 5Georgia State University, Atlanta, Georgia, United States
- 6Kennesaw State University, Kennesaw, Georgia, United States
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Background: Low back pain (LBP) is the most common reason for outpatient opioid prescribing: a quarter of patients receive prescriptions, leading to opioid use disorder (OUD) in 5%. Guideline-recommended multimodal interventions face implementation barriers, and effective modalities (e.g. electrical stimulation) lack coverage. A multimodal mechanical stimulation (M-Stim) device for LBP demonstrated safety and pain reduction, but the impact on opioid use has not been determined. Methods: As part of an NIH-funded double-blind study to reduce pain and opioid use , moderate-to-severe LBP subjects presenting to two suburban chiropractic centers were randomized to add the M-Stim device or a Transcutaneous Electrical Nerve Stimulation (TENS)unit for 30 minutes daily to other therapies. Analgesic use was reported daily for 28 days, with new prescribing followed weekly for three months. The primary outcome was prescribing in the opioid-naïve. Secondary endpoints included risk factors for prolonged use in the opioid-naive, milligram morphine equivalents (MME) for opioid users between the first and last two weeks, and prescribing compared to national rates.Results: After informed consent, 159 eligible patients were randomized to M-Stim (87) or TENS (72) (mean age 42.6 years, 54% female, BMI 30.9, NRS 5.5) between June 23, 2022, and December 31, 2023. Zero opioid-naïve M-Stim participants (n=43) received prescriptions (0% vs. 8.6%, Fisher's Exact p=0.086), and those taking opioids used significantly fewer MME (7.5[SD3.54] vs. 498.5MME [SD474.9] p<.0001) for fewer of reported days (M-Stim 2/47(4.2%)) compared to TENS (n=36, 38/102(37%), RR 0.11[95%CI 0.28-0.44] p=.0018). M-Stim significantly reduced MME in opioid users p=.02), use days for those with BMI≥30 p=.032)., and prescribing compared to national rates (9.8% vs. 25%, -63%, RR 0.32 [95%CI 0.16 to 0.66] p=0.002) while TENS did not.Conclusions: Among chiropractic patients with moderate-to-severe LBP, added use of a multimodal M-Stim device in the opioid-naïve significantly reduced factors associated with OUD compared to TENS, and reduced use days for those with BMI≥30. This novel device is a potential alternative to prescribing opioids as first-line for LBP management.
Keywords: opioid, M-Stim, DuoTherm, TENS, Low Back Pain, Multifidus
Received: 15 Apr 2025; Accepted: 16 Jun 2025.
Copyright: © 2025 Baxter, Etnoyer-Slaski, Williams, Swartout, Cohen and Lawson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Amy Lynn Baxter, Augusta University, Augusta, United States
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