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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial

Authors: Lin-lin Zhu, Jian-ying Zhou, Ling Luo, Xiang Wang, Jia-xi Peng, Sha-sha Chen, Hai-Yan Yin, Qiao-Feng Wu, Cheng-shun Zhang, Peng Lv, Yong Tang, Shu-guang Yu

Published in: Trials | Issue 1/2017

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Abstract

Background

Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA.

Methods/design

This is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (n = 69), while the conventional moxibustion group (n = 69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation.

Discussion

This study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy.

Trial registration

ClinicalTrials.gov, NCT02772055. Registered on 12 May 2016.
Appendix
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Metadata
Title
Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial
Authors
Lin-lin Zhu
Jian-ying Zhou
Ling Luo
Xiang Wang
Jia-xi Peng
Sha-sha Chen
Hai-Yan Yin
Qiao-Feng Wu
Cheng-shun Zhang
Peng Lv
Yong Tang
Shu-guang Yu
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1846-2

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