Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Breast Neoplasms

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Experimental group: 30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Control group: 30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week

Multimodal treatment: compression bandaging and manual lymph drainage.

30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.

Manual lymph drainage

Martín-Valero R., Ph D

Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.

This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way

Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.

Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.

Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema

Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.

Arm volume is measured with perimetry through truncation of cones formula

Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"

Multiple sit-to-stant test will be used to evaluate lower limbs strength.

The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™"

Simple spirometry to measure lung function with a spirometer "DATOSPIR120"

The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120)

Cardiorespiratory functional capacity as measured with six-minute walking test.

FACT-B+4 questionnaire to measure quality of life in patients with breast cancer and lymphedema. Alpha of cronbach: 0,52-0,92

EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89

QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94

HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76

QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961

The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75

Data collection was carried out through an interview in-depth semi-structured. The dimensions of the study were developed based on bibliography and objectives of the study: perceptions and experiences with multimodal treatment, ways of living with lymphedema, life style, Physical activity and exercise.

Smartphone-based application to analyze the treatment adherence of the participants

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema	NCT02165696	Arm Lymphedema ...	Multimodal trea... Manual lymph dr...	45 Years - 65 Years	University of Malaga
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema	NCT02165696	Arm Lymphedema ...	Multimodal trea... Manual lymph dr...	45 Years - 65 Years	University of Malaga

Spots Global Cancer Trial Database for compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.