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Published in: Trials 1/2019

Open Access 01-12-2019 | Acupuncture | Study protocol

Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial

Authors: Zhaoxia Chen, Dongmei Zhou, Yan Wang, Haibing Lan, Xingwu Duan, Bohua Li, Jingxia Zhao, Wei Li, Zhengrong Liu, Tingting Di, Xinwei Guo, Jinchao Zhang, Bo Li, Shuo Feng, Ping Li

Published in: Trials | Issue 1/2019

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Abstract

Background

Psoriasis is a chronic, immune-mediated disorder with chronic plaque psoriasis being the primary manifestation during the remission stage. Patients often have a slow course and long history of the disease. The refractory type of psoriasis is a stubborn rash that does not subside easily. We designed this randomized controlled trial to compare the effectiveness and relapse rates of plaque psoriasis in patients treated with either acupuncture, moxibustion or calcipotriol ointment. The ultimate aim of the study is to select an effective traditional Chinese medicine therapy for patients with plaque psoriasis.

Methods

The study will be a multicenter, prospective, randomized controlled trial that compares the effectiveness of fire needle therapy, moxibustion and calcipotriol ointment. In total, 160 patients with plaque psoriasis who meet the inclusion criteria will be recruited from three hospitals in Beijing and then randomly assigned to receive either fire needle therapy (group A1), moxibustion (group A2) or calcipotriol ointment (group B). All participants will receive an 8-week treatment and will then be followed up for another 24 weeks, with time points at weeks 12 and 24 after treatment completion. The primary outcomes to be measured are relapse rates and psoriasis area and severity index score of the target lesions. In addition, the target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion will be measured. Adverse events will be recorded for safety assessment.

Discussion

The aim of this study is to determine whether fire needle therapy or moxibustion could improve the clinical effectiveness for psoriasis lesions and reduce the relapse rate. Once completed, it will provide information regarding therapeutic evaluation on fire needle therapy or moxibustion for plaque psoriasis, which will assist clinicians in selecting the most effective treatment options for patients.

Trial registration

International Clinical Trials Registry Platform (ICTRP), ChiCTR1800019588​. Registered on 19 November 2018.
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Metadata
Title
Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial
Authors
Zhaoxia Chen
Dongmei Zhou
Yan Wang
Haibing Lan
Xingwu Duan
Bohua Li
Jingxia Zhao
Wei Li
Zhengrong Liu
Tingting Di
Xinwei Guo
Jinchao Zhang
Bo Li
Shuo Feng
Ping Li
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3736-2

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