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经皮穴位电刺激对足部和踝关节骨折手术后固定患者骨代谢的影响:一项随机对照试验研究方案。

Effect of transcutaneous electrical acupoint stimulation on bone metabolism in patients with immobilisation after foot and ankle fracture surgery: a randomised controlled trial study protocol.

机构信息

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.

Capital Medical University, Beijing Hospital of Traditional Chinese Medicine, Beijing, China.

出版信息

BMJ Open. 2022 Sep 8;12(9):e056691. doi: 10.1136/bmjopen-2021-056691.

Abstract

INTRODUCTION

Fracture is a disease with a high incidence worldwide. Foot and ankle fractures are common among fractures of the lower extremities. Foot and ankle fractures usually require surgical fixation and a period of fixed treatment, which can lead to decreased bone density. Although transcutaneous electrical acupoint stimulation (TEAS) is widely used for movement system diseases, there is minimal evidence to show the effectiveness of TEAS on patients after surgical fixation of ankle and foot fractures. This trial aims to evaluate whether TEAS can reduce bone loss in patients with immobilisation after ankle and foot fractures.

METHODS AND ANALYSIS

A randomised controlled trial will be conducted in which 60 patients will be randomly divided into two groups: (a) the control group will be treated according to the routine procedures of basic orthopaedics treatment; (b) in the treatment group, bilateral SP36, BL23 and ST36 will be performed on the basis of the control group, and the test will be performed for 30 min every other day for a total of 8 weeks. Bone turnover markers will be used as primary outcome. Secondary outcomes are composed of blood phosphorus, blood calcium and bone mineral density. Treatment safety will be monitored and recorded.

ETHICS AND DISSEMINATION

This trial is approved by the Ethics Committee of Beijing University of Chinese Medicine (2020BZYLL0611) and the Ethics Committee of Beijing Luhe Hospital (2020-LHKY-055-02), and inpatients who meet the following diagnostic and inclusion criteria are eligible to participate in this study.

TRIAL REGISTRATION NUMBER

ChiCTR 2000039944.

摘要

简介

骨折是一种全球高发疾病。足部和踝关节骨折是下肢骨折中常见的类型。足部和踝关节骨折通常需要手术固定和一段时间的固定治疗,这可能导致骨密度降低。虽然经皮穴位电刺激(TEAS)广泛应用于运动系统疾病,但很少有证据表明 TEAS 对踝关节和足部骨折手术后患者的有效性。本试验旨在评估 TEAS 是否可以减少踝关节和足部骨折后固定患者的骨丢失。

方法和分析

将进行一项随机对照试验,将 60 名患者随机分为两组:(a)对照组将按照基础骨科治疗的常规程序进行治疗;(b)在治疗组中,在对照组的基础上对双侧 SP36、BL23 和 ST36 进行治疗,每两天进行一次,每次 30 分钟,共进行 8 周。骨转换标志物将作为主要结局。次要结局包括血磷、血钙和骨密度。将监测和记录治疗安全性。

伦理和传播

本试验已获得北京中医药大学伦理委员会(2020BZYLL0611)和北京潞河医院伦理委员会(2020-LHKY-055-02)的批准,符合以下诊断和纳入标准的住院患者有资格参加本研究。

试验注册号

ChiCTR 2000039944。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a51c/9462119/bcd4f33bfbe6/bmjopen-2021-056691f01.jpg

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