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
| Autor: | Bin Wang, Dan Li, Yi Guo, Bo Chen, Xing Fang Pan, Mei Dan Zhao, Yue Wu, Zhan Yu Pan, Ren Wei Dong, Jing Rong Wen, Yong Ming Guo, Tian Yi Zhao, Chien-Hung Yeh |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty China Comparative Effectiveness Research Hot Temperature Time Factors Adolescent Breast Cancer Lymphedema Acupuncture Therapy Medicine (miscellaneous) law.invention 03 medical and health sciences Young Adult Study Protocol 0302 clinical medicine Breast cancer Randomized controlled trial law medicine Acupuncture Humans Multicenter Studies as Topic Pharmacology (medical) 030212 general & internal medicine Lymphedema Aged Randomized Controlled Trials as Topic Protocol (science) Aged 80 and over lcsh:R5-920 business.industry Common Terminology Criteria for Adverse Events Middle Aged medicine.disease Clinical trial Treatment Outcome Physical therapy Female business Complication lcsh:Medicine (General) Acupuncture Points 030217 neurology & neurosurgery |
| Zdroj: | Trials, Vol 20, Iss 1, Pp 1-10 (2019) Trials |
| ISSN: | 1745-6215 |
| Popis: | 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3491-4) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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