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Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema

Primary Purpose

Breast Cancer Lymphedema, Compression Bandages, Manual Lymphatic Drainage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Decongestive Physiotherapy
Decongestive Physiotherapy plus taping
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had unilateral BCRL and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema.

Exclusion Criteria:

  • Patients with paralysis on part of the affected arm,
  • Patients who had undergone CDP more than once within six months,
  • Patients who had an active infection,
  • Patients who had a skin disease.

Sites / Locations

  • Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Decongestive Physiotherapy

Decongestive Physiotherapy plus taping

Arm Description

This group received Complex Decongestive Physiotherapy.

This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.

Outcomes

Primary Outcome Measures

Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)
Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).

Secondary Outcome Measures

Full Information

First Posted
December 1, 2018
Last Updated
April 24, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03765996
Brief Title
Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema
Official Title
Effectiveness of Kinesio® Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
January 1, 2014 (Actual)
Study Completion Date
January 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

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

5. Study Description

Brief Summary
One of the most common conservative treatments of lymphoedema is Complex Decongestive Physiotherapy (CDP). The bandage is one of the most important components of the treatment process. The multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. However, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which showed that KT was an effective for patients with BCRL, it was applied on both the affected arm and anastomosis. One of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. This significant effect could also be seen by applying KT only to the anastomosis. In literature, however, there is no evidence to support this theory. So the aim of this study is to determine the effectiveness of KT which was applied to anastomotic regions along with CDP in the management of BCRL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema, Compression Bandages, Manual Lymphatic Drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decongestive Physiotherapy
Arm Type
Active Comparator
Arm Description
This group received Complex Decongestive Physiotherapy.
Arm Title
Decongestive Physiotherapy plus taping
Arm Type
Experimental
Arm Description
This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.
Intervention Type
Other
Intervention Name(s)
Decongestive Physiotherapy
Intervention Description
This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.
Intervention Type
Other
Intervention Name(s)
Decongestive Physiotherapy plus taping
Intervention Description
This group received CDP as same protocol of active comparator. In addition, Kinesiotaping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.
Primary Outcome Measure Information:
Title
Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)
Description
Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).
Time Frame
At baseline and at 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had unilateral BCRL and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema. Exclusion Criteria: Patients with paralysis on part of the affected arm, Patients who had undergone CDP more than once within six months, Patients who had an active infection, Patients who had a skin disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülbin Ergin, PhD
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didem Karadibak, Prof.
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tuğba Yavuzşen, Prof.
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema

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