Baxter Amy L, Etnoyer-Slaski Jena L, Williams Jessica Allia Rice, Swartout Kevin, Cohen Lindsey L, Lawson M Louise
Department of Emergency Medicine, Augusta University, Augusta GA, United States.
Harmonic Scientific LLC, Lewes, DE, United States.
Front Pain Res (Lausanne). 2025 Jul 10;6:1612572. doi: 10.3389/fpain.2025.1612572. eCollection 2025.
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.
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.
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 ( = 43) received prescriptions (0% vs. 8.6%, Fisher's exact = 0.086), and those taking opioids used significantly fewer MME [7.5 (SD 3.54) vs. 498.5 MME (SD 474.9), < 0.0001] for fewer of reported days [M-Stim 2/47 (4.2%)] compared with TENS [ = 36, 38/102 (37%), RR 0.11 (95% CI 0.28-0.44), = 0.0018]. M-Stim significantly reduced MME in opioid users [-44.6% (32.33 MME), = 0.02], use days for those with BMI ≥30 [-3 (99% CI -5.73 to -0.26), = 0.032], and prescribing compared with national rates [9.8% vs. 25%, -63%, RR 0.32 (95% CI 0.16-0.66), = 0.002] while TENS did not.
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.
https://clinicaltrials.gov/study/NCT04491175, identifier NCT04491175.
下腰痛（LBP）是门诊开具阿片类药物的最常见原因：四分之一的患者会收到处方，其中5%会导致阿片类药物使用障碍（OUD）。指南推荐的多模式干预措施常常面临实施障碍，而有效的治疗方式（如电刺激）医保未覆盖。一种用于LBP的多模式机械刺激（M-Stim）设备已证明在减轻疼痛方面具有安全性和有效性，但其对阿片类药物使用的影响尚未确定。
作为一项由美国国立卫生研究院资助的旨在减轻疼痛和减少阿片类药物使用的双盲研究的一部分，到两家郊区脊椎按摩中心就诊的中重度LBP患者被随机分组，除接受其他治疗外，每天接受30分钟的M-Stim设备治疗或经皮电刺激神经疗法（TENS）治疗。连续28天每天报告镇痛药使用情况，之后连续3个月每周跟踪新的处方开具情况。主要结局是未使用过阿片类药物的受试者的处方开具情况。次要终点包括未使用过阿片类药物的受试者长期使用阿片类药物的危险因素、阿片类药物使用者在第1周和最后2周之间的吗啡毫克当量（MME），以及与全国比率相比的处方开具情况。
在获得知情同意后，2022年6月23日至2023年12月31日期间，159名符合条件的患者被随机分配至M-Stim组（87例）或TENS组（72例）（平均年龄42.6岁，54%为女性，BMI为30.9，数字评分量表评分为5.5）。未使用过阿片类药物的M-Stim组参与者（n = 43）无一人收到处方（0% 对比8.6%，Fisher精确检验P = 0.086），并且与TENS组相比，服用阿片类药物的M-Stim组患者使用的MME显著更少[7.5（标准差3.54）对比498.5 MME（标准差474.9），P < 0.0001]，报告使用天数也更少[M-Stim组为2/47（4.2%）]对比TENS组[n = 36，38/102（37%），相对危险度0.11（95%置信区间0.28 - 0.44），P = 0.0018]。M-Stim组显著降低了阿片类药物使用者的MME[-44.6%（32.33 MME），P = 0.02]，降低了BMI≥30者的使用天数[-3天（99%置信区间 -5.73至 -0.26），P = 0.032]，并且与全国比率相比降低了处方开具率[9.8%对比25%，降低63%，相对危险度0.32（95%置信区间0.16 - 0.66），P = 0.002]，而TENS组未降低。
在患有中重度LBP的脊椎按摩患者中，与TENS组相比，未使用过阿片类药物的受试者额外使用多模式M-Stim设备显著降低了与OUD相关的因素，并减少了BMI≥30者的使用天数。这种新型设备是LBP管理中作为阿片类药物一线处方的潜在替代方案。
https://clinicaltrials.gov/study/NCT04491175，标识符NCT04491175。
