Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Study Overview
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Brief Summary
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Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.

Detailed Description
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Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG. Research design: Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre . The planned sample size was 30. Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability. Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the Clinique Investigation Unit (i+12) of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.

Official Title
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Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Other: Kinesio Taping
* Other: Compression Garment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffering from clinically significant breast cancer-related lymphedema at least since three months ago. Having a Compression Garment suitable for the lymphedema arm Exclusion Criteria: Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase). Metastasis breast cancer or other tumour. Treated with systemic chemotherapy and /or radiotherapy at that time Heart Failure or Renal Failure. Using Diuretics. Bilateral axillary lymphadenectomy. Cognitive impairment or delay that impedes understanding the study's instructions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two treatmet phases, with a four week wash out period bewtween them: A four week phase with Kinesio Taping A four week phase with compression garments.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesio Taping<br>It was done a four week phase with Kinesio Taping in the arm affected with lymphedema. | Other: Kinesio Taping<br> <br> |
| Active Comparator: Compression garment<br>It was done a four week phase with Compression garment in the arm affected with lymphedema. | Other: Compression Garment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated volumen of the upper limb. | Truncated Cone Formula. | Four weeks during each treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Goniometry of Upper Limb. | Goniometry of shoulder, elbow, wrist and hand. | Four weeks during each treatment phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression garments, Kinesio Taping, Breast Cancer-Related Lymphedema