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Completed

NCT Number: NCT03051776

Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kinesio Taping

Other

Compression Garment

Other

Primary outcomes

  1. Estimated volumen of the upper limb.

    Time frame: Four weeks during each treatment phase

    Truncated Cone Formula.

Secondary outcomes

  1. Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).

    Time frame: Four weeks during each treatment phase

    Wong-Baker faces pain rating scale.

  2. Goniometry of Upper Limb.

    Time frame: Four weeks during each treatment phase

    Goniometry of shoulder, elbow, wrist and hand.

Sponsors and collaborators

Lead sponsor

Violeta Pajero Otero

Other

Collaborators

  • Hospital Universitario 12 de Octubre
  • University of Castilla-La Mancha

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 14, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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