Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Other: Kinesio Taping; Other: Compression Garment

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Violeta Pajero Otero
• Collaborators: Hospital Universitario 12 de Octubre; University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2016
• Primary Completion (Actual): March 30, 2016
• Study Completion (Actual): March 30, 2016

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Kinesio Taping; Compression garments; Breast Cancer-Related Lymphedema
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: InveCuidRhKM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No