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      Randomised clinical trial of a manual therapy programme to reduce the evolution time of axillary web syndrome in women affected by breast cancer: study protocol

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          Abstract

          Introduction

          Breast cancer is the most common malignant tumour in women, with more than 2 million new cases annually worldwide. One of the most frequent and well-known surgical and post-actinic sequelae is post-mastectomy lymphoedema. The axillary web syndrome is another sequela that limits the functionality of the patient and delays the protocol time of administering cancer treatments; and in many cases, this sequela is misdiagnosed. This surgical sequela usually disappears spontaneously after the third month of appearance, but this implies a long period of discomfort and limitations for the patient, at the same time, it may delay the application of radiotherapy within the indicated protocol deadline (due to a need for body posture).

          Methods and analysis

          With the present quasi-experimental study, we intend to show the application of physiotherapy and stretching from the beginning of the appearance of the axillary cord, in a controlled and scheduled way by the physiotherapist. It is possible to reduce the time in which the lymphatic thrombus is present and, therefore, recover functionality and mobility, reduce pain and be able to apply treatments within the established deadline. We intend to apply this therapy into the intervention group and compare thrombus evolution time with the control group.

          Ethics and dissemination

          This trial has the approval of the Andalucía Ethics Committee (PEIBA code 1909-N1-21, reg. number 171.21).

          Trial registration number

          ClinicalTrials.gov Registry (NCT05115799).

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          Most cited references33

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          Breast Cancer Treatment

          Breast cancer will be diagnosed in 12% of women in the United States over the course of their lifetimes and more than 250 000 new cases of breast cancer were diagnosed in the United States in 2017. This review focuses on current approaches and evolving strategies for local and systemic therapy of breast cancer.
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            Cancer statistics, 2015.

            Each year the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States in the current year and compiles the most recent data on cancer incidence, mortality, and survival. Incidence data were collected by the National Cancer Institute (Surveillance, Epidemiology, and End Results [SEER] Program), the Centers for Disease Control and Prevention (National Program of Cancer Registries), and the North American Association of Central Cancer Registries. Mortality data were collected by the National Center for Health Statistics. A total of 1,658,370 new cancer cases and 589,430 cancer deaths are projected to occur in the United States in 2015. During the most recent 5 years for which there are data (2007-2011), delay-adjusted cancer incidence rates (13 oldest SEER registries) declined by 1.8% per year in men and were stable in women, while cancer death rates nationwide decreased by 1.8% per year in men and by 1.4% per year in women. The overall cancer death rate decreased from 215.1 (per 100,000 population) in 1991 to 168.7 in 2011, a total relative decline of 22%. However, the magnitude of the decline varied by state, and was generally lowest in the South (∼15%) and highest in the Northeast (≥20%). For example, there were declines of 25% to 30% in Maryland, New Jersey, Massachusetts, New York, and Delaware, which collectively averted 29,000 cancer deaths in 2011 as a result of this progress. Further gains can be accelerated by applying existing cancer control knowledge across all segments of the population. © 2015 American Cancer Society.
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              Validity of the international physical activity questionnaire short form (IPAQ-SF): A systematic review

              Background The International Physical Activity Questionnaire - Short Form (IPAQ-SF) has been recommended as a cost-effective method to assess physical activity. Several studies validating the IPAQ-SF have been conducted with differing results, but no systematic review of these studies has been reported. Methods The keywords "IPAQ", "validation", and "validity" were searched in PubMed and Scopus. Studies published in English that validated the IPAQ-SF against an objective physical activity measuring device, doubly labeled water, or an objective fitness measure were included. Results Twenty-three validation studies were included in this review. There was a great deal of variability in the methods used across studies, but the results were largely similar. Correlations between the total physical activity level measured by the IPAQ-SF and objective standards ranged from 0.09 to 0.39; none reached the minimal acceptable standard in the literature (0.50 for objective activity measuring devices, 0.40 for fitness measures). Correlations between sections of the IPAQ-SF for vigorous activity or moderate activity level/walking and an objective standard showed even greater variability (-0.18 to 0.76), yet several reached the minimal acceptable standard. Only six studies provided comparisons between physical activity levels derived from the IPAQ-SF and those obtained from objective criterion. In most studies the IPAQ-SF overestimated physical activity level by 36 to 173 percent; one study underestimated by 28 percent. Conclusions The correlation between the IPAQ-SF and objective measures of activity or fitness in the large majority of studies was lower than the acceptable standard. Furthermore, the IPAQ-SF typically overestimated physical activity as measured by objective criterion by an average of 84 percent. Hence, the evidence to support the use of the IPAQ-SF as an indicator of relative or absolute physical activity is weak.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2022
                21 September 2022
                : 12
                : 9
                : e063305
                Affiliations
                [1 ]departmentPhysiotherapy , University of Malaga , Malaga, Spain
                [2 ]departmentNursing and Physiotherapy , University of Cadiz , Cadiz, Spain
                [3 ]departmentDepartment of Physiotherapy, Faculty of Health Sciences , University of Malaga , Malaga, Spain
                Author notes
                [Correspondence to ] Dr Jesús Baltasar González Rubino; jesusbaltasar@ 123456gmail.com
                Author information
                http://orcid.org/0000-0001-7914-1014
                http://orcid.org/0000-0003-4589-4442
                http://orcid.org/0000-0003-2621-2098
                http://orcid.org/0000-0002-1664-3647
                Article
                bmjopen-2022-063305
                10.1136/bmjopen-2022-063305
                9494586
                36130744
                d311f9f0-c22c-4103-9fc8-da48bdc8456e
                © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 02 April 2022
                : 02 September 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100009473, Universidad de Málaga;
                Award ID: N/A
                Categories
                Rehabilitation Medicine
                1506
                1727
                Protocol
                Custom metadata
                unlocked

                Medicine
                rehabilitation medicine,radiotherapy,education & training (see medical education & training),breast tumours

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