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| ID | Type | Description | Link |
|---|---|---|---|
| Lymphatic Multimodal Treatment |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual lymphatic drainage and compression bandaging | Experimental | 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 |
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| Manual lymphatic drainage | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal treatment: compression bandaging and manual lymph drainage. | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perimetry | Arm volume is measured with perimetry through truncation of cones formula | Baseline, 6 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength | Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR" | Baseline, 6 weeks and 12 weeks |
| Multiple sit-to-stant test | Multiple sit-to-stant test will be used to evaluate lower limbs strength. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martín-Valero R., Ph D | Contact | 34 657834413 | rovalemas@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Málaga | Málaga | Málaga | Spain |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000073297 | Manual Lymphatic Drainage |
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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| Manual lymph drainage | Other | 30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week. |
|
| Baseline, 6 weeks and 12 weeks |
| Degree of pain | The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™" | Baseline, 6 weeks and 12 weeks |
| Pulmonary function test | Simple spirometry to measure lung function with a spirometer "DATOSPIR120" | Baseline, 6 weeks and 12 weeks |
| Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) | The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120) | Baseline, 6 weeks and 12 weeks |
| Six-minute walking test | Cardiorespiratory functional capacity as measured with six-minute walking test. | Baseline, 6 weeks and 12 weeks |
| FACT-B+4 questionnaire | FACT-B+4 questionnaire to measure quality of life in patients with breast cancer and lymphedema. Alpha of cronbach: 0,52-0,92 | Baseline, 6 weeks and 12 weeks |
| EORTIC-QLQ-C30 questionnaire | EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89 | Baseline, 6 weeks and 12 weeks |
| QLQ BR23 questionnaire | QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94 | Baseline, 6 weeks and 12 weeks |
| HADS questionnaire | HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76 | Baseline, 6 weeks and 12 weeks |
| QuickPIPPER questionnaire | QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961 | Baseline, 6 weeks and 12 weeks |
| The short version of the IPAQ | The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75 | Baseline, 6 weeks and 12 weeks |
| Qualitative measures | 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. | 6 weeks |
| Smartphone-based application | Smartphone-based application to analyze the treatment adherence of the participants | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013812 |
| Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |