Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial
BackgroundLow 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 often face implementation barriers, and effective modalities (e.g., elect...
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Frontiers Media S.A.
2025-07-01
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| Series: | Frontiers in Pain Research |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpain.2025.1612572/full |
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| author | Amy L. Baxter Amy L. Baxter Jena L. Etnoyer-Slaski Jessica Allia Rice Williams Kevin Swartout Lindsey L. Cohen M. Louise Lawson |
| author_facet | Amy L. Baxter Amy L. Baxter Jena L. Etnoyer-Slaski Jessica Allia Rice Williams Kevin Swartout Lindsey L. Cohen M. Louise Lawson |
| author_sort | Amy L. Baxter |
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| description | BackgroundLow 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 often face implementation barriers, and effective modalities (e.g., electrical stimulation) lack coverage. A multimodal mechanical stimulation (M-Stim) device for LBP has demonstrated safety and efficacy in pain reduction, but its impact on opioid use has not yet been determined.MethodsAs part of an NIH-funded double-blind study to reduce pain and opioid use, patients with moderate-to-severe LBP presenting to two suburban chiropractic centers were randomized to receive either the M-Stim device or a transcutaneous electrical nerve stimulation (TENS) unit for 30 min daily, in addition to other therapies. Analgesic use was reported daily for 28 days, with new prescribing followed weekly for 3 months. The primary outcome was prescribing in the opioid-naïve subjects. Secondary endpoints included risk factors for prolonged use in the opioid-naïve subjects, milligram morphine equivalents (MME) for opioid users between the first and last 2 weeks, and prescribing compared with national rates.ResultsAfter 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 23 June 2022 and 31 December 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 (SD 3.54) vs. 498.5 MME (SD 474.9), p < 0.0001] for fewer of reported days [M-Stim 2/47 (4.2%)] compared with TENS [n = 36, 38/102 (37%), RR 0.11 (95% CI 0.28–0.44), p = 0.0018]. M-Stim significantly reduced MME in opioid users [−44.6% (32.33 MME), p = 0.02], use days for those with BMI ≥30 [−3 (99% CI −5.73 to −0.26), p = 0.032], and prescribing compared with national rates [9.8% vs. 25%, −63%, RR 0.32 (95% CI 0.16–0.66), p = 0.002] while TENS did not.ConclusionsAmong chiropractic patients with moderate-to-severe LBP, added use of a multimodal M-Stim device in the opioid-naïve subjects significantly reduced factors associated with OUD compared with 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.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT04491175, identifier NCT04491175. |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-da5f3495109d4998b73d1fca1ff3d4b72025-08-20T03:29:02ZengFrontiers Media S.A.Frontiers in Pain Research2673-561X2025-07-01610.3389/fpain.2025.16125721612572Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trialAmy L. Baxter0Amy L. Baxter1Jena L. Etnoyer-Slaski2Jessica Allia Rice Williams3Kevin Swartout4Lindsey L. Cohen5M. Louise Lawson6Department of Emergency Medicine, Augusta University, Augusta GA, United StatesHarmonic Scientific LLC, Lewes, DE, United StatesKaizo Clinical Research Institute, Landover, MD, United StatesDepartment of Health Policy and Administration, Penn State College, University Park, PA, United StatesDepartment of Psychology, Georgia State University, Atlanta, GA, United StatesDepartment of Psychology, Georgia State University, Atlanta, GA, United StatesDepartment of Statistics and Analytical Sciences, Kennesaw State University, Kennesaw, GA, United StatesBackgroundLow 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 often face implementation barriers, and effective modalities (e.g., electrical stimulation) lack coverage. A multimodal mechanical stimulation (M-Stim) device for LBP has demonstrated safety and efficacy in pain reduction, but its impact on opioid use has not yet been determined.MethodsAs part of an NIH-funded double-blind study to reduce pain and opioid use, patients with moderate-to-severe LBP presenting to two suburban chiropractic centers were randomized to receive either the M-Stim device or a transcutaneous electrical nerve stimulation (TENS) unit for 30 min daily, in addition to other therapies. Analgesic use was reported daily for 28 days, with new prescribing followed weekly for 3 months. The primary outcome was prescribing in the opioid-naïve subjects. Secondary endpoints included risk factors for prolonged use in the opioid-naïve subjects, milligram morphine equivalents (MME) for opioid users between the first and last 2 weeks, and prescribing compared with national rates.ResultsAfter 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 23 June 2022 and 31 December 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 (SD 3.54) vs. 498.5 MME (SD 474.9), p < 0.0001] for fewer of reported days [M-Stim 2/47 (4.2%)] compared with TENS [n = 36, 38/102 (37%), RR 0.11 (95% CI 0.28–0.44), p = 0.0018]. M-Stim significantly reduced MME in opioid users [−44.6% (32.33 MME), p = 0.02], use days for those with BMI ≥30 [−3 (99% CI −5.73 to −0.26), p = 0.032], and prescribing compared with national rates [9.8% vs. 25%, −63%, RR 0.32 (95% CI 0.16–0.66), p = 0.002] while TENS did not.ConclusionsAmong chiropractic patients with moderate-to-severe LBP, added use of a multimodal M-Stim device in the opioid-naïve subjects significantly reduced factors associated with OUD compared with 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.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT04491175, identifier NCT04491175.https://www.frontiersin.org/articles/10.3389/fpain.2025.1612572/fullopioidM-StimDuoThermTENSlow back painmultifidus |
| spellingShingle | Amy L. Baxter Amy L. Baxter Jena L. Etnoyer-Slaski Jessica Allia Rice Williams Kevin Swartout Lindsey L. Cohen M. Louise Lawson Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial Frontiers in Pain Research opioid M-Stim DuoTherm TENS low back pain multifidus |
| title | Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial |
| title_full | Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial |
| title_fullStr | Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial |
| title_full_unstemmed | Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial |
| title_short | Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial |
| title_sort | preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs tens a randomized controlled trial |
| topic | opioid M-Stim DuoTherm TENS low back pain multifidus |
| url | https://www.frontiersin.org/articles/10.3389/fpain.2025.1612572/full |
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