比较电针治疗慢性足底筋膜炎的不同疗程:随机临床试验研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
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引用次数: 0

摘要

背景足底筋膜炎(PF)是足跟痛最常见的原因之一,以往的研究发现针灸能有效缓解足底筋膜炎患者的疼痛。然而,不同疗程的电针治疗对足底筋膜炎的影响尚未通过随机对照试验进行研究。方法/设计这是一项两组平行、评估者盲法随机对照试验,包括为期四周的治疗阶段和为期 12 周的随访。将招募 80 名慢性前列腺增生症患者,按 1:1 的比例随机分配接受 12 个疗程(每周 3 个疗程;每周多次电针治疗组(M 组))或 4 个疗程(每周 1 个疗程;每周单次电针治疗组(S 组))的电针治疗。研究的主要结果是应答率,即与基线相比,早晨迈出第一步时最严重的疼痛强度至少改善 50%。我们将根据意向治疗原则进行所有分析,在双侧基础上,当 P 值为 0.05 时,则认为差异显著。讨论这项前瞻性试验将为评估不同电针疗程(每周一个疗程与每周三个疗程)治疗慢性前列腺增生症的疗效和安全性提供高质量的证据。该研究旨在为电针治疗慢性脚气的最有效频率提供最新、最严谨的证据。试验注册 Clinicaltrials.gov Identifier:NCT06284993。注册日期:2024 年 2 月 17 日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparing different session regimens of electroacupuncture for chronic plantar fasciitis: Study protocol for a randomized clinical trial

Background

Plantar fasciitis (PF) is one of the most common causes of plantar heel pain, and previous studies found that acupuncture is effective for relieving pain in patients with PF. Nevertheless, the impact of different sessions of electroacupuncture on PF has not been investigated through randomized, controlled trials.

Methods/design

This is a two parallel-group, assessor-blinded, randomized controlled trial, consisting of a four-week treatment phase followed by a 12-week follow-up. Eighty patients with chronic PF will be recruited and randomly allocated to receive 12 (three sessions per week; the multiple electroacupuncture weekly treatment group (group M)) or four (one session per week; single electroacupuncture weekly treatment group (group S)) sessions of electroacupuncture treatment in a 1:1 ratio. The primary outcome to be studied is the response rate, defined as a minimum of 50 % improvement in most severe pain intensity with first steps in the morning, compared with baseline. We will perform all analyses based on the intention-to-treat principle, with differences considered significant when the P value < 0.05 on a two-sided basis.

Discussion

This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of different electroacupuncture sessions (one session per week versus three sessions per week) for chronic PF. This study aims to contribute in produce up-to-date, rigorous evidence on the most effective frequency of electroacupuncture in managing chronic PF.

Trial registration Clinicaltrials.gov Identifier: NCT06284993. Registered on February 17, 2024.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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