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Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

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

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.


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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

Resource links provided by the National Library of Medicine


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



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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051776


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

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Responsible Party: Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT03051776     History of Changes
Other Study ID Numbers: InveCuidRhKM
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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