Amy L Baxter, Jena L Etnoyer-Slaski, Jessica Allia Rice Williams, Kevin Swartout, Lindsey L Cohen, M Louise Lawson
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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.</p><p><strong>Methods: </strong>As 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.</p><p><strong>Results: </strong>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 23 June 2022 and 31 December 2023. Zero opioid-naïve M-Stim participants (<i>n</i> = 43) received prescriptions (0% vs. 8.6%, Fisher's exact <i>p</i> = 0.086), and those taking opioids used significantly fewer MME [7.5 (SD 3.54) vs. 498.5 MME (SD 474.9), <i>p</i> < 0.0001] for fewer of reported days [M-Stim 2/47 (4.2%)] compared with TENS [<i>n</i> = 36, 38/102 (37%), RR 0.11 (95% CI 0.28-0.44), <i>p</i> = 0.0018]. M-Stim significantly reduced MME in opioid users [-44.6% (32.33 MME), <i>p</i> = 0.02], use days for those with BMI ≥30 [-3 (99% CI -5.73 to -0.26), <i>p</i> = 0.032], and prescribing compared with national rates [9.8% vs. 25%, -63%, RR 0.32 (95% CI 0.16-0.66), <i>p</i> = 0.002] while TENS did not.</p><p><strong>Conclusions: </strong>Among 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.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/study/NCT04491175, identifier NCT04491175.</p>","PeriodicalId":73097,"journal":{"name":"Frontiers in pain research (Lausanne, Switzerland)","volume":"6 ","pages":"1612572"},"PeriodicalIF":2.5000,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12287057/pdf/","citationCount":"0","resultStr":"{\"title\":\"Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial.\",\"authors\":\"Amy L Baxter, Jena L Etnoyer-Slaski, Jessica Allia Rice Williams, Kevin Swartout, Lindsey L Cohen, M Louise Lawson\",\"doi\":\"10.3389/fpain.2025.1612572\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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%. 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引用次数: 0
摘要
背景：腰痛（LBP）是门诊阿片类药物处方最常见的原因：四分之一的患者接受处方，导致5%的阿片类药物使用障碍（OUD）。指南推荐的多模式干预措施往往面临实施障碍，有效的模式（如电刺激）缺乏覆盖。一种用于LBP的多模态机械刺激（M-Stim）装置已经证明了减轻疼痛的安全性和有效性，但其对阿片类药物使用的影响尚未确定。方法：作为美国国立卫生研究院资助的减少疼痛和阿片类药物使用的双盲研究的一部分，在两个郊区的脊椎按摩中心就诊的中重度腰痛患者被随机分配接受M-Stim装置或经皮神经电刺激（TENS）单元，每天30分钟，此外还有其他治疗。每天使用镇痛药28天，每周开新处方，持续3个月。主要结果是opioid-naïve受试者的处方。次要终点包括opioid-naïve受试者长期使用的危险因素，阿片类药物使用者在最初和最后2周之间的吗啡当量毫克（MME），以及与全国处方率的比较。结果：在知情同意后，159例符合条件的患者在2022年6月23日至2023年12月31日期间随机分为M-Stim（87例）或TENS（72例）（平均年龄42.6岁，54%为女性，BMI 30.9, NRS 5.5）。零opioid-naïve M-Stim参与者（n = 43）接受处方（0%比8.6%，Fisher精确p = 0.086），服用阿片类药物的患者使用的MME显著减少[7.5 （SD 3.54）比498.5 MME (SD 474.9), p n = 36,38 /102 (37%), RR 0.11 (95% CI 0.28-0.44), p = 0.0018]。M-Stim显著降低阿片类药物使用者的MME [-44.6% (32.33 MME), p = 0.02]、BMI≥30者的用药天数[-3 (99% CI -5.73 ~ -0.26), p = 0.032]，以及与全国处方率相比的处方率[9.8% vs. 25%, -63%, RR 0.32 (95% CI 0.16 ~ 0.66), p = 0.002]，而TENS则没有。结论：在中重度下腰痛的整脊患者中，opioid-naïve受试者中增加使用多模M-Stim装置与TENS相比，显著降低了与OUD相关的因素，并且BMI≥30的受试者减少了使用天数。这种新颖的装置是处方阿片类药物作为LBP管理一线的潜在替代方案。临床试验注册：https://clinicaltrials.gov/study/NCT04491175，标识符NCT04491175。
Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial.
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 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.
Methods: As 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.
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 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.
Conclusions: Among 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.
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