PDF(Pubmed)
Abstract：
Chronic non-specific low back pain (CNLBP) is one of the leading causes of disability worldwide. Acupoint embedding (ACE) is widely used in China for the treatment of chronic non-specific low back pain, but there are no rigorous randomized controlled trials (RCTs) to confirm the effectiveness and safety of ACE for chronic non-specific low back pain. In this study, we design a single-center, single-blind, prospective RCT, with the aim of evaluating the efficacy and safety of ACE for CNLBP. 82 participants with CNLBP will be randomized in a 1:1 ratio into an ACE group and a sham ACE group. Participants will receive either ACE treatment or sham ACE treatment at once every 2 weeks, for an 8-week period, and followed by 6 months of follow-up. The primary outcome will be the change in visual analog scale (VAS) scores before and after treatment. Secondary outcomes will include the Oswestry Disability Index (ODI), the Roland Morris Disability Questionnaire (RMDQ) and the Short Form 36-Health Survey (SF-36). Adverse events that occur during the course of the trial will be recorded. Data will be analyzed according to a predefined statistical analysis plan. This study was approved by the medical ethics committee of Guangzhou Panyu Hospital of Chinese Medicine (202230). Written informed consent from patients is required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2200059245). Trial results will be published in a peer-reviewed academic journal.
UNASSIGNED: https://www.chictr.org.cn, identifier ChiCTR2200059245.
UNASSIGNED: https://www.chictr.org.cn, identifier ChiCTR2200059245.
摘要：
慢性非特异性下腰痛（CNLBP）是全球残疾的主要原因之一。穴位埋线(ACE)在中国被广泛用于治疗慢性非特异性下腰痛,但尚无严格的随机对照试验(RCT)来证实ACE治疗慢性非特异性下腰痛的有效性和安全性.在这项研究中,我们设计了一个单中心，单盲,前瞻性RCT,目的是评估ACE治疗CNLBP的有效性和安全性。82名CNLBP患者将以1：1的比例随机分为ACE组和假ACE组。参与者将每2周接受一次ACE治疗或假ACE治疗，为期8周,随访6个月。主要结果将是治疗前后视觉模拟量表（VAS）评分的变化。次要结果将包括Oswestry残疾指数(ODI)，罗兰·莫里斯残疾问卷(RMDQ)和简短表格36-健康调查(SF-36)。将记录试验过程中发生的不良事件。将根据预定义的统计分析计划分析数据。本研究获得广州市番禺中医医院医学伦理委员会批准(202230)。需要患者的书面知情同意书。本试验在中国临床试验注册中心(ChiCTR2200059245)注册。试验结果将发表在同行评审的学术期刊上。
UNASSIGNED：https://www。chictr.org.cn,标识符ChiCTR2200059245。
UNASSIGNED：https://www。
