Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Not Applicable

Completed

• Conditions: Breast Cancer Lymphedema
• Interventions: Other: Kinesio Taping; Other: Compression Garment

• Registration Number: NCT03051776
• Lead Sponsor: Violeta Pajero Otero

Brief Summary

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

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 Timeline

• Study Start: 2016-01-03
• Primary Completion: 2016-03-30
• Study Completion: 2016-03-30
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Kinesio Taping	Kinesio Taping	It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.
Compression garment	Compression Garment	It was done a four week phase with Compression garment in the arm affected with lymphedema.

Primary Outcome Measures

Name	Time	Method
Estimated volumen of the upper limb.	Four weeks during each treatment phase	Truncated Cone Formula.

Secondary Outcome Measures

Name	Time	Method
Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).	Four weeks during each treatment phase	Wong-Baker faces pain rating scale.
Goniometry of Upper Limb.	Four weeks during each treatment phase	Goniometry of shoulder, elbow, wrist and hand.

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain