新型多模式机械刺激在治疗和预防慢性腰痛方面优于经皮电刺激神经疗法：一项随机对照试验。

Novel multimodal mechanical stimulation is superior to TENS to treat and prevent chronic low back pain: a randomized controlled trial.

作者信息

Baxter Amy Lynn, Etnoyer-Slaski Jena L, Tucker Owen, Williams Jessica Allia Rice, Swartout Kevin, Cohen Lindsey L, Lawson M Louise

机构信息

Department of Emergency Medicine, Augusta University, Augusta, GA, United States.

Harmonic Scientific LLC (parent company MMJ Labs LLC), Lewes, DE, United States.

出版信息

Front Pain Res (Lausanne). 2025 Aug 18;6:1625420. doi: 10.3389/fpain.2025.1625420. eCollection 2025.

BACKGROUND

Low back pain (LBP) is the leading cause of disability worldwide. Up to half of moderate-to-severe acute LBP (aLBP) progress 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 a 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 up to 6 months. Primary outcomes included PROMIS Pain Interference scores, NRS pain scores, and transition from aLBP to cLBP (Pain Interference ≥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

For 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 initial and 10-day relief. Over time, Linear Mixed Models (intention-to-treat) showed M-Stim significantly improved pain and disability for both aLBP and cLBP, ( < .001 to = .024). With higher severity, 23.9% (11/46) M-Stim users reached "no disability" (PROMIS = 40.7) vs. 7.1% (2/28) TENS users [RR 0.81 (95% CI 0.66-0.99), = 0.04]. M-Stim yielded significantly greater improvement than TENS in those with pain ≥5 years, BMI ≥30, or mechanical cLBP (all < .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, = 0.015].

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov/study/NCT04494698, identifier NCT04494698.

背景

腰痛（LBP）是全球致残的主要原因。高达一半的中重度急性腰痛（aLBP）会发展为慢性腰痛（cLBP），神经运动、筋膜和肌肉病变会导致无法手术治疗的机械性残疾。一种新型的热机械刺激（M-Stim）设备可提供随机和有针对性的振动频率，在一项试点研究中缓解了腰痛。其与积极对照相比预防cLBP或逆转残疾的疗效尚未确定。

方法

作为美国国立卫生研究院（NIH）双盲随机对照试验的一部分，159名患有非放射性中重度腰痛[数字评定量表（NRS）≥4]的脊椎按摩疗法患者被随机分配，在接受其他治疗的基础上，每天增加使用多模式M-Stim设备或四导联经皮电神经刺激（TENS）30分钟。在2022年6月至2024年7月期间，记录28天的疼痛评分、镇痛药物使用情况和设备依从性，并进行长达6个月的每周随访。主要结局包括患者报告结局测量信息系统（PROMIS）疼痛干扰评分、NRS疼痛评分以及从aLBP转变为cLBP（3个月时疼痛干扰≥55）。探索性分析检查了病情更严重的亚组，包括符合NIH研究工作组（RTF）标准的患者、肥胖患者、疼痛持续时间较长的患者，以及对顽固性无法手术治疗的机械性cLBP的共同标准进行综合分析。

结果

对于44名aLBP患者和115名cLBP患者[平均年龄42.6岁，54%为女性，体重指数（BMI）30.9（标准差6.19），NRS 5.51（标准差2.15）]，M-Stim在初始缓解和10天缓解方面不劣于TENS。随着时间推移，线性混合模型（意向性分析）显示，M-Stim在aLBP和cLBP患者中均显著改善了疼痛和残疾状况（P<0.001至P = 0.024）。在病情更严重的患者中，23.9%（11/46）的M-Stim使用者达到“无残疾”（PROMIS = 40.7），而TENS使用者为7.1%（2/28）[相对危险度（RR）0.81（95%置信区间0.66 - 0.99），P = 0.04]。在疼痛≥5年、BMI≥30或患有机械性cLBP的患者中，M-Stim的改善效果显著优于TENS（所有P<0.05）。在3个月时，aLBP患者中转为cLBP的M-Stim使用者明显更少[31.8%对72.7%，RR 0.44（95%置信区间0.23 - 0.85），需治疗人数（NNT）= 2.4，P = 0.015]。