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滞动针法肌筋膜触发点针刺治疗特发性冻结肩的随机对照试验研究方案。

Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder: study protocol for a randomized controlled trial.

机构信息

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.

Tianjin University of Traditional Chinese Medicine, Tianjin, 300073, China.

出版信息

Trials. 2020 Oct 30;21(1):901. doi: 10.1186/s13063-020-04799-w.

Abstract

BACKGROUND

There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) stuck-moving needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.

METHODS

Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital, and Qingyang Second People's Hospital in China from February 2020 to January 2021. One hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the stuck-moving needle acupuncture group, common acupuncture control group, and physical exercise control group. This trial will include a 1-week baseline period, a 3-week treatment period, and a 12-week follow-up period. During the 3 weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include measurement of pressure pain threshold (PPT), pressure pain tolerance (PTT), Oxford Shoulder Score (OSS), 36-item short form survey, and patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.

DISCUSSION

The results of this trial will allow us to compare the difference in efficacy between stuck-moving needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.

TRIAL REGISTRATION

Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). Registered on 22 December 2019. http://www.chictr.org.cn/showproj.aspx?proj=47354.

摘要

背景

有证据表明针刺治疗慢性肩痛有效,但哪种针刺模式最有效尚不清楚。我们比较了肌筋膜触发点(MTrp)滞动针法与普通针刺治疗的效果。此外,我们评估了滞动针法治疗特发性冻结肩 MTrp 以改善疼痛和运动范围的疗效和安全性。本研究旨在为特发性冻结肩患者选择有效的治疗方法。

方法

本研究采用随机对照试验,在中国庆阳市中医医院、庆阳市西峰区人民医院和庆阳市第二人民医院的三个临床中心进行,纳入 108 例冻结肩患者,按 1:1:1 的比例随机分为滞动针组、普通针刺对照组和体育锻炼对照组。该试验包括 1 周的基线期、3 周的治疗期和 12 周的随访期。在 3 周的治疗期间,患者将接受 9 次针刺治疗。主要结局指标为基线期至 12 周随访期视觉模拟量表(VAS)和关节运动范围(ROM)的变化。次要结局指标包括压力疼痛阈值(PPT)、压力疼痛耐受度(PTT)、牛津肩评分(OSS)、36 项简短调查和患者满意度评估。还将记录不良事件以进行安全性评估。

讨论

该试验的结果将使我们能够比较滞动针法 MTrp 与普通针刺治疗的疗效差异。试验结果将发表在同行评议的期刊上。

试验注册

针灸临床试验注册(ChiMCTR1900002862)和中国临床试验注册(ChiCTR1900028452)。于 2019 年 12 月 22 日注册。http://www.chictr.org.cn/showproj.aspx?proj=47354。

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