Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

• ClinicalTrials.gov Identifier: NCT03051776
• Recruitment Status: Completed
• First Posted: February 14, 2017
• Last Update Posted: October 6, 2017
• Sponsor: Violeta Pajero Otero
• Collaborators: Hospital Universitario 12 de Octubre; University of Castilla-La Mancha
• Information provided by (Responsible Party): Violeta Pajero Otero, Hospital Universitario 12 de Octubre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Lymphedema	Other: Kinesio Taping; Other: Compression Garment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment

Intervention Model Description

Two treatmet phases, with a four week wash out period bewtween them:

• A four week phase with Kinesio Taping
• A four week phase with compression garments.

• Masking: Single (Outcomes Assessor)
• Masking Description: The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.
• Primary Purpose: Treatment
• Official Title: Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
• Actual Study Start Date: January 3, 2016
• Actual Primary Completion Date: March 30, 2016
• Actual Study Completion Date: March 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Spain

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Sponsors and Collaborators

Violeta Pajero Otero

Hospital Universitario 12 de Octubre

University of Castilla-La Mancha

Investigators

• Principal Investigator: Violeta Pajero Otero, MRes; Hospital Universitario 12 de Octubre

More Information

• Responsible Party: Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit, Hospital Universitario 12 de Octubre
• ClinicalTrials.gov Identifier: NCT03051776
• Other Study ID Numbers: InveCuidRhKM
• First Posted: February 14, 2017
• Last Update Posted: October 6, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Violeta Pajero Otero, Hospital Universitario 12 de Octubre:

Compression garments; Kinesio Taping; Breast Cancer-Related Lymphedema

Additional relevant MeSH terms:

Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Lymphatic Diseases; Postoperative Complications; Pathologic Processes