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
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...
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doaj-cd2e08ed04804a359c8db0b5a0b800532020-11-25T03:41:24ZengBMCTrials1745-62152019-07-0120111010.1186/s13063-019-3491-4Comparison 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 trialChien-Hung Yeh0Tian Yi Zhao1Mei Dan Zhao2Yue Wu3Yong Ming Guo4Zhan Yu Pan5Ren Wei Dong6Bo Chen7Bin Wang8Jing Rong Wen9Dan Li10Yi Guo11Xing Fang Pan12College of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineDepartment of Combined Chinese & Western Medicine, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of CancerCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineDepartment of Combined Chinese & Western Medicine, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of CancerCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineDepartment of Traditional Chinese Medicine, Tianjin University of Traditional Chinese MedicineCollege of Acupuncture and Massage, Tianjin University of Traditional Chinese MedicineAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3491-4AcupunctureLymphedemaBreast cancer |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 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 Trials Acupuncture Lymphedema Breast cancer |
author_facet |
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 |
author_sort |
Chien-Hung Yeh |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-07-01 |
description |
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. |
topic |
Acupuncture Lymphedema Breast cancer |
url |
http://link.springer.com/article/10.1186/s13063-019-3491-4 |
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