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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
| University of Castilla-La Mancha | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPT+P | Active Comparator | Complex Physical Therapy plus Pressotherapy during three weeks |
|
| Kinesio Taping | Experimental | Kinesio Taping during three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex Physical Therapy plus Pressotherapy | Other |
| ||
| Kinesio Taping |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment. | Truncated Cone Formula for Volume from upper limb circumference. | Four weeks during each treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the DASH Outcome Measure. | Validated questionnaire about Disability of the Arm,Shoulder and Hand. | Four weeks during each treatment phase |
| Score of the TTDL questionnaire. | a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published). |
| Measure | Description | Time Frame |
|---|---|---|
| Age. | Years old at the beginning of the study. | First day of treatment of the first phase. |
| Time since axillary surgery. | Time since axillary surgery in years at the beginning of the study. |
Inclusion Criteria:
Exclusion Criteria:
1) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.
7) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).
female
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| Name | Affiliation | Role |
|---|---|---|
| Violeta Pajero Otero, MRes | Hospital Universitario 12 de Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35642305 | Derived | Pajero Otero V, Garcia Delgado E, Martin Cortijo C, Rodriguez Ramos ML, De Carlos Iriarte E, Gil Garcia A, Romay-Barrero H, Avendano-Coy J. Intensive complex physical therapy combined with intermittent pneumatic compression versus Kinesio taping for treating breast cancer-related lymphedema of the upper limb: A randomised cross-over clinical trial. Eur J Cancer Care (Engl). 2022 Sep;31(5):e13625. doi: 10.1111/ecc.13625. Epub 2022 May 31. |
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
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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:
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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.
|
| Four weeks during each treatment phase |
| Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS). | Wong-Baker faces pain rating scale. | Four weeks during each treatment phase |
| Stage of the lymphedema. | I, IIA, IIB III, IV. | Four weeks during each treatment phase |
| Goniometry of Upper Limb. | Goniometry of shoulder, elbow and wrist. | Four weeks during each treatment phase |
| Body Mass Index. | The weight in kilograms divided by the square of the height in metres (kg/m2). | Four weeks during each treatment phase |
| First day of treatment of the first phase. |
| Type of axillary surgery. | Lymphadenectomy or Sentinel Lymph Node Biopsy. | First day of treatment of the first phase. |
| Type of breast surgery. | Lumpectomy or mastectomy. | First day of treatment of the first phase. |
| Radiotherapy for Breast Cancer. | Yes or not. | First day of treatment of the first phase. |
| Time since the appearance of the BCRL. | Years since the BCRL appeared. | First day of treatment of the first phase. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |