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评估草药治疗与工作相关的慢性下腰痛的疗效和安全性:一项多中心、随机、对照临床试验的研究方案。

Evaluation of the efficacy and safety of herbal medicine for treating work-related chronic low back pain: A study protocol for a multicenter, randomized, controlled, clinical trial.

作者信息

Ko Youme, Jang Bo-Hyoung, Oh Min-Seok, Kim Sun Joong, Cha Yun-Yeop, Lee Eun Jung, Song Yun-Kyung, Ko Seung-Gyu

机构信息

Department of Science in Korean Medicine, Graduate School, Kyung Hee University.

Department of Korean Rehabilitation Medicine, College of Korean Medicine, Dae-Jeon University, Daejeon.

出版信息

Medicine (Baltimore). 2019 Jul;98(30):e16466. doi: 10.1097/MD.0000000000016466.

Abstract

INTRODUCTION

In Korea, low back pain (LBP) which is occupation-related symptom is one of the major health issues owing to rapid industrialization. Even traditional Korean medicine has the long history in pain treatment, there still has been lack of supporting evidence on herbal prescription itself. Sogyeonghwalhyeol-tang, a Korean herbal medicine prescription, has been suggested as a medication for treating chronic LBP as well as work-related pains.

OBJECTIVE

This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang on work-related chronic LBP patients.

METHOD

This trial is designed as a multicenter, randomized, controlled, clinical trial. Seventy-two participants who have chief complaint of LBP in Korean medicine rehabilitation center will be randomly assigned to ether Sogyeonghwalhyeol-tang group or placebo group with a ratio of 1:1. They will receive assigned drugs in 4 weeks and follow-up for 2 weeks.

DISCUSSION

The result of this study will provide the valuable information for efficacy and safety of Sogyeonghwalhyeol-tang for patients with work-related chronic LBP.

摘要

引言

在韩国,由于快速工业化,与职业相关的症状——腰痛(LBP)是主要的健康问题之一。尽管传统韩医学在疼痛治疗方面有着悠久的历史,但草药处方本身仍缺乏支持证据。速淸火烈汤,一种韩国草药处方,已被建议作为治疗慢性腰痛以及与工作相关疼痛的药物。

目的

本研究旨在评估草药速淸火烈汤对与工作相关的慢性腰痛患者的临床疗效和安全性。

方法

本试验设计为多中心、随机、对照临床试验。在韩国医学康复中心以腰痛为主诉的72名参与者将以1:1的比例随机分配到速淸火烈汤组或安慰剂组。他们将在4周内接受分配的药物,并随访2周。

讨论

本研究结果将为速淸火烈汤治疗与工作相关的慢性腰痛患者的疗效和安全性提供有价值的信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87ea/6708960/91d52e00eaf5/medi-98-e16466-g001.jpg

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