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Published in: Trials 1/2019

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

Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial

Authors: Chien-Hung Yeh, Tian Yi Zhao, Mei Dan Zhao, Yue Wu, Yong Ming Guo, Zhan Yu Pan, Ren Wei Dong, Bo Chen, Bin Wang, Jing Rong Wen, Dan Li, Yi Guo, Xing Fang Pan

Published in: Trials | Issue 1/2019

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Abstract

Background

Lymphedema is the most common complication after breast cancer treatment, but management of lymphedema remains a clinical challenge. Several studies have reported the beneficial effect of acupuncture for treating breast cancer-related lymphedema (BCRL). Our objective is to verify the effectiveness of warm acupuncture on BCRL and compare the effectiveness of a local distribution acupoint combination with a local-distal acupoint combination for BCRL.

Methods

This is a study protocol for a multicenter, three-arm parallel, assessor blinded, randomized controlled trial. A total of 108 participants diagnosed as BCRL will be randomly allocated in equal proportions to a local distribution acupoint (LA) group, a local-distal acupoint (LDA) group, or a waiting-list (WL) group. The LA and LDA groups will receive 20 acupuncture treatment over 8 weeks with local distribution acupoint combination and local-distal acupoint combination, respectively. The WL group will receive acupuncture treatment after the study is concluded. The primary outcome is the mean change in inter-limb circumference difference from baseline to week 8. The secondary outcomes include volume measurement, skin hardness, common terminology criteria for adverse events 4.03 (edema limbs criteria), stages of lymphedema from the International Society of Lymphology, Disabilities of the Arm, Shoulder and Hand questionnaire, and the Medical Outcome Study 36-item Short-form Health Survey.

Discussion

This study aims to provide data on warm acupuncture as an effective treatment for BCRL and at the same time compare the effectiveness of different acupoint combinations.

Trial registration

ClinicalTrials.gov: Identifier NCT03373474. Registered on 14th December 2017.
Appendix
Available only for authorised users
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Metadata
Title
Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial
Authors
Chien-Hung Yeh
Tian Yi Zhao
Mei Dan Zhao
Yue Wu
Yong Ming Guo
Zhan Yu Pan
Ren Wei Dong
Bo Chen
Bin Wang
Jing Rong Wen
Dan Li
Yi Guo
Xing Fang Pan
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3491-4

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