Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Overview

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 Title of Study: “Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2016

Detailed 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.

Interventions

  • Other: Kinesio Taping
  • Other: Compression Garment

Arms, Groups and Cohorts

  • Experimental: Kinesio Taping
    • It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.
  • Active Comparator: Compression garment
    • It was done a four week phase with Compression garment in the arm affected with lymphedema.

Clinical Trial Outcome Measures

Primary Measures

  • Estimated volumen of the upper limb.
    • Time Frame: Four weeks during each treatment phase
    • Truncated Cone Formula.

Secondary Measures

  • 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.
  • Goniometry of Upper Limb.
    • Time Frame: Four weeks during each treatment phase
    • Goniometry of shoulder, elbow, wrist and hand.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Violeta Pajero Otero
  • Collaborator
    • Hospital Universitario 12 de Octubre
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit – Hospital Universitario 12 de Octubre
  • Overall Official(s)
    • Violeta Pajero Otero, MRes, Principal Investigator, Hospital Universitario 12 de Octubre

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