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

NCT ID: NCT03765996

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2015-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decongestive Physiotherapy

This group received Complex Decongestive Physiotherapy.

Group Type: ACTIVE_COMPARATOR

Decongestive Physiotherapy

Intervention Type: 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 plus taping

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

Group Type: EXPERIMENTAL

Decongestive Physiotherapy plus taping

Intervention Type: 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.

Interventions

Decongestive Physiotherapy

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

Decongestive Physiotherapy plus taping

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Ertan Sahinoglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülbin Ergin, PhD

Role: PRINCIPAL_INVESTIGATOR

European University of Lefke

Didem Karadibak, Prof.

Role: STUDY_DIRECTOR

Dokuz Eylul University

Tuğba Yavuzşen, Prof.

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2301-GOA

Identifier Type: -

Identifier Source: org_study_id