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瑞波克斯电疗法在疼痛管理中的疗效:一项随机双盲假对照交叉试验

Efficacy of Rebox Electrotherapy in Pain Management: A Randomized Double-Blind Sham-Controlled Crossover Trial.

作者信息

Martuliak Igor, Chvála Ľuboš, Ferenčík Miroslav, Fabián Vratislav, Slovák Matěj

机构信息

Department of Algesiology of Slovak Medical University, F.D. Roosevelt University Hospital with Policlinic Banska Bystrica, Banska Bystrica, Slovakia.

Faculty of Electrical Engineering, Czech Technical University in Prague, Prague, Czech Republic.

出版信息

Pain Ther. 2025 Sep 3. doi: 10.1007/s40122-025-00768-w.

Abstract

INTRODUCTION

Rebox therapy is a form of noninvasive transcutaneous electrotherapy, which delivers microcurrent kilohertz-frequency pulses in multiple points over the target area. Despite decades of use in pain management, clinical evidence supporting Rebox remains inconclusive, with a lack of rigorous sham-controlled trials. This study aimed to evaluate its analgesic effect in a single-center, randomized, double-blind, sham-controlled crossover trial.

METHODS

The study included consecutive patients with non-cancer nociceptive pain with average pain intensity ≥ 4 on a numerical rating scale (NRS), and pain duration of 2-12 weeks (de novo or acutely exacerbated chronic pain). Patients were randomized (1:1) into two arms based on the sequence of stimulation periods. Each period consisted of eight sessions of either Rebox or sham treatment, administered every other working day, with a 1-week washout period. The primary outcome was the difference in the reduction of pain intensity (average and worst pain in the last 24 h) following active versus sham stimulation.

RESULTS

Seventy-one patients completed the study, with musculoskeletal back pain being the most common indication (n = 60). Compared to the sham, Rebox significantly reduced both average pain (NRS difference: 2.2, 95% CI 0.8-3.6, Cohen's d = 0.75, p = 0.002) and worst pain (NRS difference: 2.3, 95% CI 1.2-3.5, Cohen's d = 0.91, p < 0.001). A significant placebo analgesic effect was observed only in the sham-first arm. The treatment was well tolerated, with only minor and transient side effects.

CONCLUSION

Rebox demonstrated a significant analgesic effect compared to the sham. The treatment was safe and well tolerated. These findings support integrating Rebox into clinical pain management, warranting further investigation in larger trials.

摘要

引言

瑞波疗法是一种非侵入性经皮电疗法,它在目标区域的多个点传递微电流千赫兹频率脉冲。尽管在疼痛管理中使用了数十年,但支持瑞波疗法的临床证据仍然不确凿,缺乏严格的假对照试验。本研究旨在通过一项单中心、随机、双盲、假对照交叉试验评估其镇痛效果。

方法

该研究纳入了连续的非癌性伤害感受性疼痛患者,其数字评分量表(NRS)平均疼痛强度≥4,疼痛持续时间为2至12周(新发或急性加重的慢性疼痛)。根据刺激期的顺序,患者被随机(1:1)分为两组。每个周期包括八次瑞波治疗或假治疗,每隔一个工作日进行一次,有1周的洗脱期。主要结局是主动刺激与假刺激后疼痛强度降低的差异(过去24小时的平均疼痛和最严重疼痛)。

结果

71名患者完成了研究,肌肉骨骼背痛是最常见的适应症(n = 60)。与假治疗相比,瑞波疗法显著降低了平均疼痛(NRS差异:2.2,95%CI 0.8 - 3.6,Cohen's d = 0.75,p = )和最严重疼痛(NRS差异:2.3,95%CI 1.2 - 3.5,Cohen's d = 0.91,p < )。仅在假治疗先进行的组中观察到显著的安慰剂镇痛效果。该治疗耐受性良好,只有轻微和短暂的副作用。

结论

与假治疗相比,瑞波疗法显示出显著的镇痛效果。该治疗安全且耐受性良好。这些发现支持将瑞波疗法纳入临床疼痛管理,值得在更大规模的试验中进一步研究。 (注:原文中部分p值未完整给出具体数值)

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