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

NCT03765996 | Completed Results

• 1 other identifier: 2301-GOA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Lymphedema; Compression Bandages; Manual Lymphatic Drainage

Outcome Measures

Primary Outcomes (1)

• 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).

  At baseline and at 4 weeks

Study Arms (2)

Decongestive Physiotherapy

ACTIVE COMPARATOR

This group received Complex Decongestive Physiotherapy.

Other: Decongestive Physiotherapy

Decongestive Physiotherapy plus taping

EXPERIMENTAL

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

Other: Decongestive Physiotherapy plus taping

Interventions

Decongestive Physiotherapy OTHER

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.

Decongestive Physiotherapy

Decongestive Physiotherapy plus taping OTHER

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.

Decongestive Physiotherapy plus taping

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ertan Şahinoğlu
• Organization: Dr. İsmail Atabek Physiotherapy and Rehabilitation Center

ertan.sahinoglu@hotmail.com

+90 532 647 86 53

Study Officials

• Gülbin Ergin, PhD

  European University of Lefke

  PRINCIPAL INVESTIGATOR

• Didem Karadibak, Prof.

  Dokuz Eylul University

  STUDY DIRECTOR

• Tuğba Yavuzşen, Prof.

  Dokuz Eylul University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 6, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Locations

TU (1)