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Complex Physical Therapy plus Pressotherapy during three weeks

Complex Physical Therapy plus Pressotherapy

Kinesio Taping

Violeta Pajero Otero, MRes

This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.

2. Kinesio Taping.

Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.

Complex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.

GOALS:

Main objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.

Secondary objectives:

To analyze possible changes after each therapy in:

* DASH (Disability Arm, Shoulder and Hand) outcome measure score.
* TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).
* Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).
* Goniometry of Upper Limb.

METHODOLOGY OF THE STUDY:

Design: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.

Interventions: The two therapies compared are:

* CPT+ P.
* KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.

3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases.

Open design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin.

Interventions: The two therapies compared are:

* CPT+ P.
* KT.

The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.

Comparison of Techniques for Breast Cancer-Related Lymphedema.

Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

Time since axillary surgery in years at the beginning of the study.

Lymphadenectomy or Sentinel Lymph Node Biopsy.

Truncated Cone Formula for Volume from upper limb circumference.

Validated questionnaire about Disability of the Arm,Shoulder and Hand.

a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).

The weight in kilograms divided by the square of the height in metres (kg/m2).

Hospital Universitario 12 de Octubre

University of Castilla-La Mancha

Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

Women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos.

Standard treatment for lymphedema perform complex physical therapy associated with a muscular strength protocol.Muscle-building arm with load

Compare the standard treatment of lymphedema, by complex physical therapy versus TFC associated with the upper limbs strengthening exercises.

complex physical therapy

evaluate through the questionnaires fatigue and quality of life of patients with lymphedema (FACT- F and Inventory BECK)

Evaluate treatment of lymphedema, with in the quality of life and depression

Gil Facina

The stage and lymphedema size can be detrimental to the quality of life and health of women, because the increase in circumference and member of the weight causes limitations in activities. Previous studies have shown that patients with lymphedema should not perform high intensity exercises, these exercises would cause the increase of lymphedema. Already, in current studies show that muscle strength exercises when properly applied, with controlled intensity and time, can help to reduce lymphedema. Thus, the main objective of this study is to compare the standard treatment of lymphedema through complex physical therapy versus the application of strengthening exercises for upper limbs together with complex physical therapy. The study design is a randomized controlled clinical trial. Participate in the study 50 patients, who will be allocated into two groups, group 1 (n = 25): Complex Physical Therapy; Group 2 (n = 25): Complex physical therapy in an exercise protocol, which will receive treatment twice a week for eight weeks. All patients will receive treatment and will be informed of the free and informed consent form at the beginning of the research. They will be met: the report cards, dynamometer testing and filling out questionnaires at the beginning and end of the study.

This study will be conducted in Onco Mastology clinic of the Department of Mastology the Department of Gynecology, Federal University of São Paulo (UNIFESP) - Paulista School of Medicine (EPM), in which patients will be recruited, selected and informed about the study objectives , its relevance, activities to be developed and the possibility of improvement and remedy your questions and concerns about the disease.The study design is a randomized controlled clinical trial. To define the treatment, 50 patients are allocated to two groups, group 1 (n = 25) Group 2 (n = 25) that receive treatment twice a week for eight weeks. Physical examination will be performed, completing the consent form, evaluation form, and questionnaires. Group 1 standard treatment : 25 women with lymphedema , perform complex physical therapy with manual lymphatic drainage, compression bandaging and exercises linfomiocinéticos . Treatment was given twice a week , 8 consecutive weeks , 6 sessions.Group 2 standard treatment + muscle strength : 25 women with lymphedema , perform complex physical therapy, manual lymphatic drainage, compression bandaging and linfomiocinéticos exercises and strengthening exercises with load.Treatment was given twice a week , 8 consecutive weeks , 16 sessions.

Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy

Lymphedema Treatment of Post-surgical Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy

Brawn average difference between the upper limbs with and without lymphedema.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Techniques for Breast Cancer-Related Lymphedema.	NCT03051750	Breast Cancer L...	Complex Physica... Kinesio Taping	18 Years -	Hospital Universitario 12 de Octubre
Comparison of Techniques for Breast Cancer-Related Lymphedema.	NCT03051750	Breast Cancer L...	Complex Physica... Kinesio Taping	18 Years -	Hospital Universitario 12 de Octubre
Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy	NCT02574780	Lymphedema	complex physica... Evaluate treatm...	18 Years -	Federal University of São Paulo
Lymphedema Upper Limb of Breast Cancer Through Muscle Strengthening Associated With Complex Physical Therapy	NCT02574780	Lymphedema	complex physica... Evaluate treatm...	18 Years -	Federal University of São Paulo

Spots Global Cancer Trial Database for complex physical therapy