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

Not Applicable

Completed

• Conditions: Breast Cancer Lymphedema; Manual Lymphatic Drainage; Compression Bandages
• Interventions: Other: Decongestive Physiotherapy plus taping; Other: Decongestive Physiotherapy

• Registration Number: NCT03765996
• Lead Sponsor: Dokuz Eylul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2014-01-01
• Study Completion: 2015-01-01
• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Status Verified: 2020-04
• Results First Submitted: 2020-04-03
• Results First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-24
• Results First Posted: 2020-04-27
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decongestive Physiotherapy plus taping	Decongestive Physiotherapy plus taping	This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.
Decongestive Physiotherapy	Decongestive Physiotherapy	This group received Complex Decongestive Physiotherapy.

Primary Outcome Measures

Name	Time	Method
Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)	At baseline and at 4 weeks	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).

Trial Locations

Locations (1)

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center; 🇹🇷 İzmir, Turkey