Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Violeta Pajero Otero

Status: Completed

Conditions: Breast Cancer Lymphedema

Treatments: Other: Compression Garment; Other: Kinesio Taping

Study type: Interventional

Funder types: Other

Identifiers

NCT03051776

InveCuidRhKM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Kinesio Taping

Experimental group

Description:

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

Treatment:

Other: Kinesio Taping

Compression garment

Active Comparator group

Description:

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

Treatment:

Other: Compression Garment