Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Breast Cancer Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051776
• Other study ID #: InveCuidRhKM
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: October 5, 2017
• Start date: January 3, 2016
• Est. completion date: March 30, 2016

Study information

• Verified date: October 2017
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2016
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Kinesio Taping

• Compression Garment

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Violeta Pajero Otero	Hospital Universitario 12 de Octubre, University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated volumen of the upper limb.	Truncated Cone Formula.	Four weeks during each treatment phase
Secondary	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
Secondary	Goniometry of Upper Limb.	Goniometry of shoulder, elbow, wrist and hand.	Four weeks during each treatment phase