CLINICAL TRIAL article
Front. Pain Res.
Sec. Non-Pharmacological Treatment of Pain
Volume 6 - 2025 | doi: 10.3389/fpain.2025.1625420
Novel Multimodal Mechanical Stimulation is Superior to TENS to Treat and Prevent Chronic Low Back Pain: A Randomized Controlled Trial
Provisionally accepted
Amy Lynn Baxter1*
Jena L Etnoyer-Slaski2Owen Tucker3Jessica Allia Rice Williams4Kevin Swartout5
Lindsey L Cohen5M Louise Lawson6- 1Augusta University, Augusta, United States
- 2Kaizo Clinical Research Institute, Landover, MD, United States
- 3Emory University, Atlanta, GA, United States
- 4The Pennsylvania State University, University Park, PA, United States
- 5Georgia State University, Atlanta, GA, United States
- 6Kennesaw State University, Kennesaw, GA, United States
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Background: Low back pain (LBP) is the leading cause of disability worldwide. Up to half of moderate-to-severe acute LBP (aLBP) progresses to chronic (cLBP), with neuromotor, fascial, and muscle pathology contributing to inoperable mechanical disability. A novel thermomechanical stimulation (M-Stim) device delivering stochastic and targeted vibration frequencies relieved LBP in a pilot. Efficacy versus an active control, for cLBP prevention, or reversing disability was undetermined.Methods: As part of an National Institutes of Health (NIH) double-blind, randomized controlled trial, 159 chiropractic patients with non-radiating moderate-to-severe LBP (Numeric Rating Scale (NRS) ≥4) were randomized to add either the multimodal M-Stim device or 4-lead transcutaneous electrical nerve stimulation (TENS) for 30 minutes daily to other therapies. Between June 2022 and July 2024, pain scores, analgesic use, and device adherence were recorded for 28 days, with weekly follow-up upto 6 months. Primary outcomes included PROMIS Pain Interference scores, NRS pain scores, and transition from aLBP to cLBP (PROMIS T ≥55 at 3 months). Exploratory analyses examined higher-severity subgroups, including those meeting NIH Research Task Force (RTF) criteria, obesity, longer pain duration, and an integrated analysis with common criteria for intractable inoperable mechanical cLBP.Results: Of 44 aLBP and 115 cLBP participants (mean age 42.6, 54% female, BMI 30.9 [SD 6.19], NRS 5.51 [SD 2.15]), M-Stim was noninferior to TENS for early pain reduction. Linear Mixed Models(intention-to-treat)showed significantly improved pain and disability resolution with M-Stimfor both aLBP and cLBP, (p<.001 to p=.024). With higher severity,23.7% (11/48) M-Stim users reached "no disability" (PROMIS =40.7) versus 6.7% (2/28) TENS users (RR 0.81 [95% CI 0.66-0.99], p=0.04). M-Stim yielded significantly greater improvement than TENS in those with pain ≥5 years, BMI ≥30, or mechanical cLBP (all p<.05). Significantly fewer aLBP M-Stim users transitioned to cLBP at 3 months (31.8% vs. 72/7%, RR 0.44 [95% CI 0.23-0.85], NNT=2.4, p=0.015).A multimodal M-Stim device reduced progression to cLBP significantly more than TENS. Both devices reduced pain initially,, but M-Stim reduced pain and disability significantly more over time, particularly in cLBP subsets with higher severity, duration, or BMI.
Keywords: Mechanical low back pain, prevention, focal mechanical vibration, PROMIS (Patient-Reported Outcomes Measurement Information System), spine biomechanics, Vibration &, Acute Low Back Pain (aLBP)
Received: 08 May 2025; Accepted: 08 Jul 2025.
Copyright: © 2025 Baxter, Etnoyer-Slaski, Tucker, 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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