电子针灸鞋治疗慢性下腰痛的疗效：双盲随机对照试验。
Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial.
机构信息
Division of Acupuncture and Moxibustion, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
School of Traditional Chinese Medicine, Chang Gung University, Taoyuan, Taiwan.
出版信息
J Med Internet Res. 2020 Oct 26;22(10):e22324. doi: 10.2196/22324.
BACKGROUND
Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use.
OBJECTIVE
The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain.
METHODS
In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits.
RESULTS
After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups.
CONCLUSIONS
EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.
背景
慢性下背痛是一种常见的问题，与高成本相关，包括与医疗保健相关的成本以及因缺勤或生产力下降而导致的间接成本。先前的研究表明，针刺或电针可以缓解下背痛。电子针灸鞋（EAS）是本研究中设计的一种新型装置。该装置将针刺和经皮神经电刺激的特性结合起来用于临床应用。
目的
本研究旨在评估 EAS 对慢性下背痛患者的疗效。
方法
在这项前瞻性双盲随机对照研究中，分析了 83 名患有慢性下背痛的患者的数据。患者来我们诊所就诊 20 次，并进行评估和治疗。患者被随机分配接受 EAS 加安慰剂非甾体抗炎药（NSAIDs）（EAS 组，n=42）或假 EAS 加 NSAIDs（NSAID 组，n=41）。在基线、每次 EAS 治疗前后以及最后一次治疗后 2 周评估视觉模拟评分（VAS）评分和运动范围。记录达到疼痛缓解的时间。在第 2、14 和 20 次就诊时评估生活质量。
结果
在 6 周的治疗后，EAS 组在每次就诊的治疗成功率均高于 NSAID 组，意向治疗（ITT）和方案（PP）分析均显示，但仅在 ITT 分析的第 16 次就诊时观察到显著差异（EAS 组：31/37，84%和 NSAID 组：21/34，62%；P=.04）。EAS 组在每次就诊的 VAS 评分从基线开始的变化大于 NSAID 组，ITT 和 PP 分析均显示，在 ITT 分析的第 5 次和第 9 次就诊时观察到显著差异（P=.048 和 P=.048，分别）。在第 2 次和第 4 次就诊时，左侧旋转的差异具有统计学意义（P=.049 和 P=.03，分别）。在每次就诊和两组的生活质量方面，治疗前后的 VAS 评分均无显著差异。
结论
EAS 可能成为口服 NSAIDs 禁忌的慢性下背痛患者的可靠替代治疗工具。
试验注册
ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.
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