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

Xing Fang Pan¹  Ren Wei Dong¹  Bo Chen¹  Yue Wu¹  Yong Ming Guo¹  Tian Yi Zhao¹  Chien-Hung Yeh¹  Dan Li¹  Mei Dan Zhao¹  Jing Rong Wen¹  Bin Wang²  Zhan Yu Pan²  Yi Guo³ 

[1] College of Acupuncture and Massage, Tianjin University of Traditional Chinese Medicine;Department of Combined Chinese & Western Medicine, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer;Department of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine;

关键词: Acupuncture;    Lymphedema;    Breast cancer;   

DOI  :  10.1186/s13063-019-3491-4

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown