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Open Access 01-12-2018 | Study protocol

Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial

Authors: Huanfang Xu, Hong Zhao, Liping Kang, Shixi Huang, Yin Shi, Wei Su, Mingjuan Han, Wenyan Wang, Chunyan Wang, Yuan Zhang, Lanping Guo

Published in: Trials | Issue 1/2018

Abstract

Background

According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA.

Methods

This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study.

Discussion

This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion.

Trial registration

Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007. Registered on 29 February 2016.

Available only for authorised users

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Title: Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
Authors: Huanfang Xu
Hong Zhao
Liping Kang
Shixi Huang
Yin Shi
Wei Su
Mingjuan Han
Wenyan Wang
Chunyan Wang
Yuan Zhang
Lanping Guo
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2794-1

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Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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