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Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

NCT ID: NCT03051776

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-03

Study Completion Date

2016-03-30

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.

Conditions

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Breast Cancer Lymphedema

Keywords

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Compression garments Kinesio Taping Breast Cancer-Related Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Kinesio Taping

It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.

Group Type EXPERIMENTAL

Kinesio Taping

Intervention Type OTHER

Compression garment

It was done a four week phase with Compression garment in the arm affected with lymphedema.

Group Type ACTIVE_COMPARATOR

Compression Garment

Intervention Type OTHER

Interventions

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Kinesio Taping

Intervention Type OTHER

Compression Garment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.
2. Having a Compression Garment suitable for the lymphedema arm

Exclusion Criteria

1. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
2. Metastasis breast cancer or other tumour.
3. Treated with systemic chemotherapy and /or radiotherapy at that time
4. Heart Failure or Renal Failure.
5. Using Diuretics.
6. Bilateral axillary lymphadenectomy.
7. Cognitive impairment or delay that impedes understanding the study's instructions.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role collaborator

Violeta Pajero Otero

OTHER

Sponsor Role lead

Responsible Party

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Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Violeta Pajero Otero, MRes

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

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Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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InveCuidRhKM

Identifier Type: -

Identifier Source: org_study_id