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银质针疗法治疗慢性非特异性下腰痛的疗效:一项前瞻性、单中心、随机、平行对照临床试验。

Efficacy of silver needle therapy for the treatment of chronic nonspecific low back pain: a prospective, single-center, randomized, parallel-controlled clinical trial.

作者信息

Hu Xuesong, Dong Shaoxing, Zhang Bing, Wang Xuan, Yin Yanwei, Liu Chuansheng, Yu Junmin, Wu Xing, Xu Fenghu, Meng Chao

机构信息

Department of Pain, the People's Hospital of Yuxi City, The 6th Affiliated Hospital of Kunming Medical University, Yuxi, China.

Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.

出版信息

Trials. 2021 Jan 21;22(1):75. doi: 10.1186/s13063-021-05040-y.

Abstract

BACKGROUND

Chronic nonspecific low back pain (CNSLBP) troubles approximately 30% of people worldwide. Silver needle therapy (SNT) is a treatment method to relieve soft tissue pain through heating. Therefore, this study aimed to observe the effects of SNT on CNSLBP.

METHODS

In this study, 100 patients were randomly divided into 2 groups: silver needle (SN) group and control group (n = 50). In the SN group, patients received SNT and physiotherapy, while patients received physiotherapy alone in the control group. At the 6-month follow-up, the numerical rating scale (NRS), Oswestry Disability Index (ODI), Short-Form 12 of quality of life (SF-12), the natural logarithms of low-frequency measurement (InLF), and the natural logarithms of high-frequency measurement (InHF) of heart rate variability (HRV) were recorded.

RESULTS

In both groups, NRS, ODI, SF-12 scores, and HRV at 2 weeks after treatment were improved and maintained for 6 months. Compared with the control group, more significant improvements were observed in the NRS and SF-12 scores at 1, 2, 3, and 6 months and in the ODI scores at 1 and 2 months in the SN group (P <  0.05). However, there was no significant difference between the groups in the ODI scores at 3 and 6 months. InLF and InHF in the SN group were higher than those in the control group at 3 and 6 months (P <  0.05).

CONCLUSIONS

SNT relieved pain and improved quality of life and autonomic nerve activity, especially parasympathetic nerve, in patients with CNSLBP, without serious complications.

TRIAL REGISTRATION

Chinese Clinical Trial Registry No. ChiCTR-OOC-17013237 . Registered on November 11, 2017.

摘要

背景

慢性非特异性下腰痛(CNSLBP)困扰着全球约30%的人口。银质针疗法(SNT)是一种通过加热来缓解软组织疼痛的治疗方法。因此,本研究旨在观察银质针疗法对慢性非特异性下腰痛的疗效。

方法

本研究中,100例患者被随机分为两组:银质针组(SN组)和对照组(n = 50)。SN组患者接受银质针疗法和物理治疗,而对照组患者仅接受物理治疗。在6个月的随访中,记录数字评分量表(NRS)、Oswestry功能障碍指数(ODI)、生活质量简表12(SF - 12)、心率变异性(HRV)的低频测量自然对数(InLF)和高频测量自然对数(InHF)。

结果

两组患者治疗后2周时的NRS、ODI、SF - 12评分及HRV均有所改善,并维持6个月。与对照组相比,SN组在1、2、3和6个月时的NRS和SF - 12评分以及在1和2个月时的ODI评分改善更为显著(P < 0.05)。然而,两组在3和6个月时的ODI评分无显著差异。SN组在3和6个月时的InLF和InHF高于对照组(P < 0.05)。

结论

银质针疗法可缓解慢性非特异性下腰痛患者的疼痛,改善生活质量和自主神经活动,尤其是副交感神经,且无严重并发症。

试验注册

中国临床试验注册中心编号ChiCTR - OOC - 17013237。于2017年11月11日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a010/7818943/8ef5445cc00f/13063_2021_5040_Fig1_HTML.jpg

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