Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial

María Nieves Muñoz-Alcaraz, Luis Ángel Pérula-de-Torres, Jesús Serrano-Merino, Antonio José Jiménez-Vílchez, María Victoria Olmo-Carmona, María Teresa Muñoz-García, Cruz Bartolomé-Moreno, Bárbara Oliván-Blázquez, Rosa Magallón-Botaya, María Nieves Muñoz-Alcaraz, Luis Ángel Pérula-de-Torres, Jesús Serrano-Merino, Antonio José Jiménez-Vílchez, María Victoria Olmo-Carmona, María Teresa Muñoz-García, Cruz Bartolomé-Moreno, Bárbara Oliván-Blázquez, Rosa Magallón-Botaya

Abstract

Background: Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema.

Methods: Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II).

Results: Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat.

Discussion: It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations.

Limitations: The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation.

Trial registration: This trial was registered in ClinicalTrials.gov ( NCT03762044 ). Date of registration: 23 November 2018. Prospectively Registered.

Keywords: Activity-oriented proprioceptive antiedema therapy (TAPA in Spanish); Breast cancer (BC) - lymphedema (L); Complex decongestive therapy (CDT); Health-related quality of life (HRQOL); Occupational therapy (OT).

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Fig. 1
Fig. 1
Study flow design
Fig. 2
Fig. 2
Gantt’s study diagram

References

    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
    1. Asociación Española Contra el Cáncer (Spanish Association Againts Cancer). Todo lo que Necesitas Saber (All you need to know). Available from: . Accessed 13 Mar 2019.
    1. Baxter MF, Newman R, Longpré SM, Polo KM. Occupational therapy’s role in cancer survivorship as a chronic condition. Am J Occup Ther. 2017;71(3):7103090010P1–P7.
    1. Cuello Villaverde E, Guerola Soler N, López RA. Perfil clínico y terapéutico del linfedema postmastectomía. Rehabilitación. 2003;37(1):22–32. doi: 10.1016/S0048-7120(03)73329-5.
    1. Puigdellivol Serafí C, Alonso Álvarez B. Guia de orientación diagnóstica y terapéutica del linfedema [Internet]. 2017. 148 p. Available from: .
    1. Teijeiro JFC, Torres MEC, Touza AL, Cuñarro MG, Estévez LP, Varela AS. Prevención del cáncer de mama en atención primaria. Aten Primaria. 2000;26(6):419–427. doi: 10.1016/S0212-6567(00)78693-8.
    1. María Eugenia Bravo M, Octvio Peralta M, Paulina Neira V, Laura Itriago G. Prevención y seguimiento del cáncer de mama, según categorización de factores de riesgo y nivel de atención. Rev Médica Clín Las Condes. 2015;24(4):578–587. doi: 10.1016/S0716-8640(13)70198-6.
    1. Loh SY, Musa AN. Methods to improve rehabilitation of patients following breast cancer surgery: a review of systematic reviews. Breast Cancer Targets Ther. 2015;7:81–98. doi: 10.2147/BCTT.S47012.
    1. Silver JK, Gilchrist LS. Cancer rehabilitation with a focus on evidence-based outpatient physical and occupational therapy interventions. Am J Phys Med Rehabil. 2011;90(SUPPL.5):5–15. doi: 10.1097/PHM.0b013e31820be4ae.
    1. Stout NL, Silver JK, Raj VS, Rowland J, Gerber L, Cheville A, et al. Toward a National Initiative in Cancer rehabilitation: recommendations from a subject matter expert group. Arch Phys Med Rehabil 2016;97(11):2006–2015. Available from: 10.1016/j.apmr.2016.05.002.
    1. Morgan P. Best practice for the management of lymphoedema. International consensus. London: The lymphoedema framework; 2006.
    1. Alba Conejo E, Alvarez M, Bayo E, Del Río S, Doctor M, Dueñas B, et al. Proceso Asistencial Integrado Cáncer de Mama. [Internet]. Consejería de salud. Junta de Andalucía. 2011 [cited 2019 Sep 12]. 175 p. Available from: .
    1. Jeffs E, Ream E, Taylor C, Bick D. Clinical effectiveness of decongestive treatments on excess arm volume and patient-centered outcomes in women with early breast cancer-related arm lymphedema. JBI Database Syst Rev Implement Rep. 2018;16(2):453–506. doi: 10.11124/JBISRIR-2016-003185.
    1. Preston NJ, Seers K, Mortimer PS. Physical therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database Syst Rev. 2004;(4). [cited 2019 Feb 3] Available from: 10.1002/14651858.CD003141.pub2.
    1. Lasinski BB, Thrift KMK, Squire DC, Austin MK, Smith KM, Wanchai A, et al. A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM R 2012;4(8):580–601. Available from: 10.1016/j.pmrj.2012.05.003.
    1. Longhurst E, Dylke ES, Kilbreath SL. Use of compression garments by women with lymphoedema secondary to breast cancer treatment. Support Care Cancer. 2018;26(8):2625–2632. doi: 10.1007/s00520-018-4093-5.
    1. Navarro-Brazález B, Sánchez-Sánchez B. El vendaje en el tratamiento fisioterapéutico del linfedema secundario a cancer de mama: Una serie de casos. Fisioterapia 2014;36(1):49–53. Available from: 10.1016/j.ft.2013.03.004.
    1. Tambour M, Holt M, Speyer A, Christensen R, Gram B. Manual lymphatic drainage adds no further volume reduction to complete decongestive therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial. Br J Cancer 2018;119(10):1215–1222. Available from: 10.1038/s41416-018-0306-4.
    1. Luctkar-Flude M, Aiken A, McColl MA, Tranmer J. What do primary care providers think about implementing breast cancer survivorship care? Curr Oncol. 2018;25(3):196–205. doi: 10.3747/co.25.3826.
    1. Lpez-Martn M, De Carlos Iriarte E. El papel de la escuela de linfedema y la cinesiterapia en la prevencin y el tratamiento del linfedema. Rehabilitacion. 2010;44(SUPPL. 1):49–53. doi: 10.1016/j.rh.2010.06.005.
    1. Forner Cordero I, Maldonado Garrido D, Muñoz LJ. Necesidad de información para la prevención del linfedema posmastectomía. Rehabilitación. 2003;37(3):141–144. doi: 10.1016/S0048-7120(03)73357-X.
    1. Smoot B, Boyd BS, Byl N, Dodd M. Mechanosensitivity in the upper extremity following breast cancer treatment. J Hand Ther 2014;27(1):4–11. Available from: 10.1016/j.jht.2013.08.021.
    1. de la Rosa Díaz I, Torres Lacomba M, Cerezo Téllez E, Díaz del Campo Gómez-Rico C, Gutiérrez Ortega C. Accessory joint and neural mobilizations for shoulder range of motion restriction after breast cancer surgery: a pilot randomized clinical trial. J Chiropr Med. 2017;16(1):31–40. Available from: 10.1016/j.jcm.2016.09.001.
    1. Boudier-Revéret M, Gilbert KK, Allégue DR, Moussadyk M, Brismée JM, Sizer PS, et al. Effect of neurodynamic mobilization on fluid dispersion in median nerve at the level of the carpal tunnel: a cadaveric study. Musculoskelet Sci Pract. 2017;31:45–51. doi: 10.1016/j.msksp.2017.07.004.
    1. Ha KJ, Lee SY, Lee H, Choi SJ. Synergistic effects of proprioceptive neuromuscular facilitation and manual lymphatic drainage in patients with mastectomy-related lymphedema. Front Physiol. 2017;8(NOV):1–8.
    1. Ha K-J, Choi SJ. Effects of PNF rehabilitation exercise on lymphedema following mastectomy for breast cancer. Med Sci Sport Exerc. 2014;46:368. doi: 10.1249/.
    1. Hwang WT, Chung SH, Chung MS, Lee KH, Kim T. Effect of proprioceptive neuromuscular facilitation D2 flexion and breathing exercises on lymphedema without a short stretch compression bandage. J Phys Ther Sci. 2015;27(10):3341–3343. doi: 10.1589/jpts.27.3341.
    1. Kärki A, Simonen R, Mälkiä E, Selfe J. Impairments, activity limitations and participation restrictions 6 and 12 months after breast cancer operation. J Rehabil Med. 2005;37(3):180–188.
    1. Esteban-Vico JR. Villaverde-Dom??nech E, Del Caz DP, Klenner-Mu??oz C, Sim??n-Sanz E. Vendaje autoadherente en el tratamiento integral y rehabilitador de la mano quemada. Cir Plast Ibero-Latinoamericana. 2016;42(4):347–353.
    1. Franks PJ, Moffatt CJ, Murray S, Reddick M, Tilley A, Schreiber A. Evaluation of the performance of a new compression system in patients with lymphoedema. Int Wound J. 2013;10(2):203–209. doi: 10.1111/j.1742-481X.2012.00958.x.
    1. Moffatt CJ, Franks PJ, Hardy D, Lewis M, Parker V, Feldman JL. A preliminary randomized controlled study to determine the application frequency of a new lymphoedema bandaging system. Br J Dermatol. 2012;166(3):624–632. doi: 10.1111/j.1365-2133.2011.10731.x.
    1. González Viejo MA, Condón Huerta MJ, Lecuona Navea M, Val Lampreave L, Laínez Zaragüeta I, Rezusta Sagasti L, et al. Coste-efectividad del tratamiento del linfedema postmastectomía en españa. Rehabilitación. 2001;35(2):68–73. doi: 10.1016/S0048-7120(01)73143-X.
    1. Martínez Jaimez P. Evaluación del riesgo de linfedema. Adaptación española del Wannan Medical College Scoring System. Barcelona: Universitat Internacional de Catalunya; 2017. . Accessed 1 Nov 2018.
    1. de Miguel Benadiba C, Martín López de Abajo M, Teixeira Taborda A, Sánchez Tarifa P, Gijón Moreno L. Gestión económica del tratamiento del linfedema. Rev Senol y Patol Mamar. 2016;29(4):157–162. Available from: 10.1016/j.senol.2016.06.003.
    1. Román Lizano CR. Diseño de un programa de linfedema en el Instituto Nacional de enfermedades Neoplásicas de Lima 2017. Lima: Universidad Cesar Vallejo; 2018. . Accessed 1 Nov 2018.
    1. Zarate V. Evaluaciones económicas en salud: Conceptos básicos y clasificación (Economic evaluations in healthcare: Basic concepts and classification). Rev Med Chile. 2010;138(Supl 2):93–7.
    1. Servicio Andaluz de Salud. Rehabilitación y fisioterapia en Atención Primaria. Guía de Procedimientos. Sevilla; Consejería de Salud (Gobierno de Andalucía); 2003. . Accessed 3 Feb 2019.
    1. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013;46(1):1–11.
    1. Johnson KC, Kennedy AG, Henry SM. Clinical measurements of lymphedema. Lymphat Res Biol 2014;12(4):216–221. Available from: .
    1. Kizil R, Dilek B, Şahin E, Engin O, Soylu AC, Akalin E, et al. Is continuous passive motion effective in patients with lymphedema? a randomized controlled trial. Lymphat Res Biol. 2018;16(3):263–269. [cited 2019 Feb 3]Available from: .
    1. Martín ML, Hernández MA, Avendaño C, Rodríguez F, Martínez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011;11(1):94. doi: 10.1186/1471-2407-11-94.
    1. Arias-Cuadrado A, Lvarez-Vzquez MJ, Martn-Mourelle R, Villarino-Daz JC. Clnica, clasificacin y estadiaje del linfedema. Rehabilitacion. 2010;44(SUPPL. 1):29–34. doi: 10.1016/j.rh.2010.06.007.
    1. Romero Cullerés G, Almendáriz JA. Linfedema después de la cirugía por cáncer de mama. Estudio de la incidencia y factores de riesgo en 113 pacientes. Rehabilitación. 2004;38(2):72–77. doi: 10.1016/S0048-7120(04)73431-3.
    1. Servicio de Medicina Física y Rehabilitación. Rehabilitación del linfedema. Actualización y protocolo. Medicina (B Aires) [Internet]. 2008;72. Available from: .
    1. López Martín M, Valencia Álvarez FJ, González González R, Rodríguez Salvanés FJ, Crespo Cobo P, Hernández García MA. Validación de herramienta informática para el cálculo de linfedema en pacientes con afectación unilateral de extremidad superior. Rehabilitación. 2011;45(2):127–133. doi: 10.1016/j.rh.2011.03.008.
    1. Hervás MT, Navarro Collado MJ, Peiró S, Rodrigo Pérez JL, López Matéu P, Martínez Tello I. Versión Española del cuestionario DASH. Adaptación transcultural, fiabilidad, validez y sensibilidad a los cambios. Med Clin (Barc) 2006;127(12):441–447. doi: 10.1157/13093053.
    1. Beaton DE, Wright JG, Katz JN, Amadio P, Bombardier C, Cole D, et al. Development of the QuickDASH: COmparison of three item-reduction approaches. J Bone Jt Surg - Ser A. 2005;87(5):1038–1046.
    1. Alonso Álvarez B. Cuestionario de calidad de vida ULL-27: un instrumento específico para pacientes con linfedema de miembro superior tras cáncer de mama . Adaptación transcultural y validación de su versión española 2016; Available from: .
    1. Herdman M, Badia X, Berra S. El EuroQol-5D: una alternativa sencilla para la medición de la calidad de vida relacionada con la salud en atención primaria. Atención Primaria. 2001;28(6):425–429. doi: 10.1016/S0212-6567(01)70406-4.

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