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温针灸治疗强直性脊柱炎的疗效:一项随机对照试验方案。

Efficacy of warming needle moxibustion in the treatment of ankylosing spondylitis: A protocol of a randomized controlled trial.

机构信息

Department of Orthopedic Surgery, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.

出版信息

Medicine (Baltimore). 2021 May 21;100(20):e25850. doi: 10.1097/MD.0000000000025850.

Abstract

BACKGROUND

Ankylosing spondylitis is a recurrent autoimmune disease, which has a high disability rate and seriously affects patients' daily life. Conventional treatment cannot effectively solve the clinical problems of patients, and long-term medication is accompanied by adverse reactions. The evidence shows that warming needle moxibustion has advantages in the treatment of ankylosing spondylitis, but there is still a lack of clinical studies on warm acupuncture alone and long-term follow-up.

METHODS

This is a prospective randomized controlled trial to study the efficacy and safety of needle warming through moxibustion in the treatment of ankylosing spondylitis. It was approved by the Ethics Committee of Clinical Research of our hospital. Patients were randomly assigned to an observation group or a control group. The patients were followed up for 6 months after 30 days of treatment. Observation indicators include; activity index, functional ability, Bath Ankylosing Spondylitis Metrology Index, inflammatory indicators, adverse reactions, and so on. Finally, SPASS 22.0 software is used for statistical analysis of the data.

DISCUSSION

This study will evaluate the clinical efficacy of warming needle moxibustion in the treatment of ankylosing spondylitis. The results of this study will provide a reference basis for the clinical use of warm needle moxibustion in the treatment of ankylosing spondylitis.

TRIAL REGISTRATION

OSF Registration number: DOI 10.17605/OSF.IO/GWPX3.

摘要

背景

强直性脊柱炎是一种反复发作的自身免疫性疾病,致残率高,严重影响患者的日常生活。常规治疗不能有效解决患者的临床问题,且长期用药伴有不良反应。有证据表明,温针灸在治疗强直性脊柱炎方面具有优势,但单独温针治疗的临床研究和长期随访仍缺乏。

方法

这是一项前瞻性随机对照试验,旨在研究艾灸温针治疗强直性脊柱炎的疗效和安全性。该研究已获得我院临床研究伦理委员会的批准。患者被随机分配到观察组或对照组。治疗 30 天后,对患者进行 6 个月的随访。观察指标包括:活动指数、功能能力、Bath 强直性脊柱炎计量指数、炎症指标、不良反应等。最后,使用 SPASS 22.0 软件对数据进行统计分析。

讨论

本研究将评估艾灸温针治疗强直性脊柱炎的临床疗效。该研究的结果将为温针治疗强直性脊柱炎的临床应用提供参考依据。

试验注册

OSF 注册号:DOI 10.17605/OSF.IO/GWPX3。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b414/8137021/39ca41b56150/medi-100-e25850-g001.jpg

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