Jéssica Malena Pedro da Silva, Raul Denner Duarte Araújo, Suzana Sales de Aguiar, Erica Alves Nogueira Fabro, Marcus Vinicius de Mello Pinto, Luiz Claudio Santos Thuler, Anke Bergmann
{"title":"在乳腺癌相关淋巴水肿的控制阶段使用可调节压力裹布的有效性、安全性和依从性:随机对照试验。","authors":"Jéssica Malena Pedro da Silva, Raul Denner Duarte Araújo, Suzana Sales de Aguiar, Erica Alves Nogueira Fabro, Marcus Vinicius de Mello Pinto, Luiz Claudio Santos Thuler, Anke Bergmann","doi":"10.1177/02692155241270921","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema.</p><p><strong>Design and setting: </strong>Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil.</p><p><strong>Participants: </strong>Women in control phase of the breast cancer-related lymphedema.</p><p><strong>Interventions: </strong>Compared use of ACWs versus compressive mesh.</p><p><strong>Main measures: </strong>Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval.</p><p><strong>Results: </strong>Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group (<i>p</i> = .041, ES 0.20), with improved functionality (<i>p</i> = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume (<i>p</i> = .023, ES 0.26) and demonstrated improvement functionality (<i>p</i> = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome-excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups (<i>p</i> > .05) at both times.</p><p><strong>Conclusions: </strong>Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.</p>","PeriodicalId":10441,"journal":{"name":"Clinical Rehabilitation","volume":" ","pages":"1481-1494"},"PeriodicalIF":2.6000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy, safety of and adherence to adjustable compression wraps in the control phase of breast cancer-related lymphedema: A randomized controlled trial.\",\"authors\":\"Jéssica Malena Pedro da Silva, Raul Denner Duarte Araújo, Suzana Sales de Aguiar, Erica Alves Nogueira Fabro, Marcus Vinicius de Mello Pinto, Luiz Claudio Santos Thuler, Anke Bergmann\",\"doi\":\"10.1177/02692155241270921\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema.</p><p><strong>Design and setting: </strong>Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil.</p><p><strong>Participants: </strong>Women in control phase of the breast cancer-related lymphedema.</p><p><strong>Interventions: </strong>Compared use of ACWs versus compressive mesh.</p><p><strong>Main measures: </strong>Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval.</p><p><strong>Results: </strong>Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group (<i>p</i> = .041, ES 0.20), with improved functionality (<i>p</i> = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume (<i>p</i> = .023, ES 0.26) and demonstrated improvement functionality (<i>p</i> = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome-excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups (<i>p</i> > .05) at both times.</p><p><strong>Conclusions: </strong>Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.</p>\",\"PeriodicalId\":10441,\"journal\":{\"name\":\"Clinical Rehabilitation\",\"volume\":\" \",\"pages\":\"1481-1494\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Rehabilitation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/02692155241270921\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"REHABILITATION\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Rehabilitation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/02692155241270921","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/9 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"REHABILITATION","Score":null,"Total":0}
Efficacy, safety of and adherence to adjustable compression wraps in the control phase of breast cancer-related lymphedema: A randomized controlled trial.
Objective: To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema.
Design and setting: Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil.
Participants: Women in control phase of the breast cancer-related lymphedema.
Interventions: Compared use of ACWs versus compressive mesh.
Main measures: Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval.
Results: Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group (p = .041, ES 0.20), with improved functionality (p = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume (p = .023, ES 0.26) and demonstrated improvement functionality (p = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome-excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups (p > .05) at both times.
Conclusions: Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.
期刊介绍:
Clinical Rehabilitation covering the whole field of disability and rehabilitation, this peer-reviewed journal publishes research and discussion articles and acts as a forum for the international dissemination and exchange of information amongst the large number of professionals involved in rehabilitation. This journal is a member of the Committee on Publication Ethics (COPE)