Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial
| Autor: | Liuying Song, Meiyu Dai, Gechen Zhou, Huiru Zhu, Yan Zou, Jinwan Li, Xumexiang Liu, Jifei Chen, Shengming Dai, Zheng Peng, Shengzhang Lin, Xiaolan Lv, Fengxian Qin, Baoyu He, Yujie Huang |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Breast Cancer Lymphedema Acupuncture Therapy Breast cancer related lymphedema Trial 03 medical and health sciences Study Protocol 0302 clinical medicine Quality of life Multicenter trial Acupuncture medicine Protocol Humans Multicenter Studies as Topic 030212 general & internal medicine Adverse effect Randomized Controlled Trials as Topic Protocol (science) business.industry Incidence (epidemiology) lcsh:Other systems of medicine General Medicine lcsh:RZ201-999 medicine.disease Lymphedema Treatment Outcome Complementary and alternative medicine 030220 oncology & carcinogenesis Physical therapy Quality of Life Female business Acupuncture Points Breast Cancer Related Lymphedema |
| Zdroj: | BMC Complementary and Alternative Medicine BMC Complementary and Alternative Medicine, Vol 17, Iss 1, Pp 1-9 (2017) |
| ISSN: | 1472-6882 |
| Popis: | Background Although various treatments for breast cancer related lymphedema exist, there is still a need for a more effective and convenient approach. Pilot studies and our clinical observations suggested that acupuncture may be a potential option. This study aims to verify the effectiveness of acupuncture on BCRL and evaluate its safety using a rigorously designed trial. Methods/Design Women who are clinically diagnosed as unilateral BCRL, with a 10% to 40% increase in volume compared to the unaffected arm, will be recruited. Following baseline assessment, participants will be randomized to either the real acupuncture group or sham-acupuncture group at a ratio of 1:1, and given a standard real acupuncture or sham-acupuncture treatment accordingly on both arms followed by the same usual care of decongestive therapy. Volume measurements of both arms will be performed for every participant after each treatment. Data collected at baseline and the last session will be used to calculate the primary outcome and secondary outcomes. Other data will be exploited for interim analyses and trial monitoring. The primary outcome is the absolute reduced limb volume ratio. Secondary outcomes are incidence of adverse events and change in quality of life. A t test or non-parameter test will be used to compare the difference between two groups, and assess the overall effectiveness of acupuncture using the SPSS software (version 12). Discussion This study will help expand our knowledge about the effectiveness of acupuncture on BCRL, and how acupuncture might be used in the management of this condition. Acupuncture may be a promising complement or alternative to conventional lymphedema treatment methods, if its effectiveness is confirmed. Trial registration ClinicalTrials.gov NCT02803736 (Registered on October 31, 2016). Electronic supplementary material The online version of this article (10.1186/s12906-017-1980-0) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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