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经皮椎体后凸成形术治疗骨质疏松性椎体压缩骨折后残余腰痛的针灸疗效和安全性的系统评价和荟萃分析方案。

Protocol for systematic review and meta-analysis on the efficacy and safety of acupuncture for residual low back pain after percutaneous kyphoplasty in patients with osteoporotic vertebral compression fracture.

机构信息

Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China

出版信息

BMJ Open. 2024 Aug 29;14(8):e082272. doi: 10.1136/bmjopen-2023-082272.

Abstract

INTRODUCTION

Osteoporotic vertebral compression fracture (OVCF) is a common complication in elderly patients with osteoporosis. Despite undergoing percutaneous kyphoplasty (PKP) treatment, a significant percentage of OVCF patients (1.8% to 31.9%) continue to experience residual low back pain. While acupuncture has shown promise in relieving this pain, there is currently no systematic review on its efficacy specifically for residual low back pain after PKP in OVCF patients. This project aims to evaluate the effectiveness and safety of acupuncture as a treatment for this condition.

METHODS AND ANALYSIS

A comprehensive search will be conducted, including manual and electronic searches of literature published. Various databases such as MEDLINE, PubMed, EMBASE, Web of Science, Cochrane Library, International Clinical Trial Registration Platform, China National Knowledge Network, China Biomedical Literature Database, China Scientific Journal Database and Wan-fang Database will be explored. Additional sources like bibliographies and meeting minutes will also be searched. All randomised controlled clinical trials related to acupuncture for treating residual low back pain after PKP in OVCF patients will be included. Two researchers will independently perform study selection, data extraction and quality assessment. The primary outcome measure will be pain relief assessed using a visual analogue scale (VAS) or other validated scales. Secondary outcomes include effectiveness, Oswestry dysfunction index (ODI), quality of life questionnaire (QUALEFFO-41), follow-up relapse rate and adverse events. If feasible, a meta-analysis using RevMan V.5.3 software will be conducted. Otherwise, descriptive or subgroup analyses will be performed. Database searches will commence after the publication of this agreement, with an estimated commencement date of 1 August 2024.

ETHICS AND DISSEMINATION

Ethical approval is not required since this review does not involve individual patient data. The findings will be disseminated through peer-reviewed journals or relevant conferences.

PROSPERO REGISTRATION NUMBER

CRD42023478838.

摘要

简介

骨质疏松性椎体压缩骨折(OVCF)是老年骨质疏松症患者的常见并发症。尽管接受了经皮椎体后凸成形术(PKP)治疗,但仍有相当比例的 OVCF 患者(1.8%至 31.9%)持续存在残余腰痛。尽管针灸在缓解这种疼痛方面显示出了一定的效果,但目前尚无专门针对 OVCF 患者 PKP 后残余腰痛的针灸疗效的系统评价。本项目旨在评估针灸治疗这种疾病的有效性和安全性。

方法和分析

将进行全面搜索,包括手动和电子搜索已发表的文献。将探索各种数据库,如 MEDLINE、PubMed、EMBASE、Web of Science、Cochrane 图书馆、国际临床试验注册平台、中国国家知识网络、中国生物医学文献数据库、中国科学期刊数据库和万方数据库。还将搜索参考文献和会议记录等其他来源。将纳入所有与针灸治疗 OVCF 患者 PKP 后残余腰痛相关的随机对照临床试验。两名研究人员将独立进行研究选择、数据提取和质量评估。主要结局测量指标将是使用视觉模拟量表(VAS)或其他经过验证的量表评估疼痛缓解情况。次要结局包括疗效、Oswestry 功能障碍指数(ODI)、生活质量问卷(QUALEFFO-41)、随访复发率和不良事件。如果可行,将使用 RevMan V.5.3 软件进行荟萃分析。否则,将进行描述性或亚组分析。数据库搜索将在本协议发布后开始,预计开始日期为 2024 年 8 月 1 日。

伦理和传播

由于本综述不涉及个体患者数据,因此不需要伦理批准。研究结果将通过同行评议期刊或相关会议传播。

PROSPERO 注册号:CRD42023478838。

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