电磁感应治疗非特异性腰痛：一项前瞻性随机假对照临床试验。

Electromagnetic Induction for Treatment of Unspecific Back Pain: A Prospective Randomized Sham-Controlled Clinical Trial.

机构信息

Center for Diagnostic and Health, Munich, Germany.

Center for Diagnostic and Health, Munich, Germany; University of Sousse. Faculty of Medicine of Sousse, Laboratory of Physiology, Sousse, Tunisia.

出版信息

J Rehabil Med. 2023 Apr 28;55:jrm00389. doi: 10.2340/jrm.v55.3487.

DOI:10.2340/jrm.v55.3487

PMID:37115201

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10166141/

Abstract

OBJECTIVE

To evaluate the effects of high-energy pulsed electromagnetic fields on unspecific back pain.

METHODS

A prospective, randomized, sham-controlled clinical trial with repeated measurements was performed. The study included 5 visits (V0 to V4) with 3 interventions during V1, V2 and V3. Sixty-one patients aged between 18 and 80 years with unspecific back pain (acute inflammatory diseases and specific causes were reasons for exclusion) were included. The treatment group (n = 31) received 1-2 pulses/s, with an intensity of 50 mT, and an electric field strength of at least 20 V/m on 3 consecutive weekdays for 10 min each time. The control group (n = 30) received a comparable sham therapy. Pain intensity (visual analogue scale), local oxyhaemoglobin saturation, heart rate, blood pressure, and perfusion index were evaluated before (b) and after (a) V1 and V3 interventions. Change in visual analogue scale for V1 (ChangeV1a-b) and V3 (ChangeV3a-b), and ChangeData between V3a and V1b (ChangeV3a-V1b) for the remaining data were calculated (results were mean (standard deviation) (95% confidence interval; 95% CI)).

RESULTS

Concerning the visual analogue scale: (i) compared with the control group, the treatment group had higher ChangeV1a-b (-1.25 (1.76) (95% CI -1.91 to -0.59) vs -2.69 (1.74) (95% CI -3.33 to -2.06), respectively), and comparable Change V3a-b (-0.86 (1.34) (95% CI -1.36 to -0.36) vs -1.37 (1.03) (95% CI -1.75 to 0.99), respectively); and (ii) there was a significant marked decrease in Change V3a-1b in the treatment group compared with the control group (-5.15 (1.56) (95% CI -5.72 to -4.57) vs -2.58 (1.68) (95% CI -3.21 to -1.96), p = 0.001, respectively). There was no significant ChangeV3a-V1b in local oxyhaemoglobin saturation, heart rate, blood pressure or perfusion index between the 2 groups and for the same group (before vs after).

CONCLUSION

Non-thermal, non-invasive electromagnetic induction therapy had a significant and rapid influence on unspecific back pain in the treatment group.

摘要

目的

评估高能量脉冲电磁场对非特异性背痛的疗效。

方法

这是一项前瞻性、随机、假对照的临床试验，采用重复测量设计。研究共纳入 5 次就诊（V0 至 V4），V1、V2 和 V3 期间分别进行 3 次干预。61 例年龄在 18 至 80 岁之间的非特异性背痛患者（急性炎症性疾病和特定病因是排除的原因）入组。治疗组（n=31）接受 1-2 次/秒、50 mT 强度和至少 20 V/m 电场强度的电磁感应治疗，连续 3 个工作日，每次 10 分钟。对照组（n=30）接受类似的假治疗。在 V1 和 V3 干预前（b）和后（a）评估疼痛强度（视觉模拟评分）、局部氧血红蛋白饱和度、心率、血压和灌注指数。计算 V1（ChangeV1a-b）和 V3（ChangeV3a-b）的视觉模拟评分变化，以及 V3a 和 V1b 之间的变化数据（ChangeV3a-V1b）（结果为均值（标准差）（95%置信区间；95%CI））。

结果

关于视觉模拟评分：（i）与对照组相比，治疗组的 ChangeV1a-b 更高（-1.25（1.76）（95%CI -1.91 至 -0.59） vs -2.69（1.74）（95%CI -3.33 至 -2.06）），而 Change V3a-b 无差异（-0.86（1.34）（95%CI -1.36 至 -0.36） vs -1.37（1.03）（95%CI -1.75 至 0.99））；（ii）治疗组 V3a-1b 的变化明显低于对照组（-5.15（1.56）（95%CI -5.72 至 -4.57） vs -2.58（1.68）（95%CI -3.21 至 -1.96），p=0.001）。两组间及同组内（治疗前后），局部氧血红蛋白饱和度、心率、血压或灌注指数的 ChangeV3a-V1b 均无显著差异。