Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy

Comparison of Kinesiotaping and Pressure Garment on Old Adult Women With Secondary Upper Extremity Lymphedema Following Mastectomy: A Randomized Controlled Trial

Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems

This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer.

Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Other: Kinesio Taping

Detailed Description

66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. The participants were randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio taping (KT) and pressure garment (PG) included 33 patients.

The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.

All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Dr Dalia Kamel
  • Giza, Egypt
    • Dr Sayed Tanatwy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side.

Exclusion Criteria:

• The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Active Comparator: Study group; Kinesio Taping	Other: Kinesio Taping; Kinesio Taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb circumference	The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index	Shoulder Pain and Disability Index (SPADI) survey was created to assess the shoulder pain and disability. It incorporates of 13 items that assess two domains: a 5 items that assess pain and an 8 items that evaluate disability.	1 month
Hand grip strength	Hand grip strength was evaluated by Dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, United Kingdom). The grip strength was measured while the patient was in a standing position with adducted shoulder, flexed elbow 90 degrees and forearm in mid position.	1 month
Quality of life	The quality of life was assessed by utilizing cancer-specific questionnaire (EORTC) QLQ-C30 before and after intervention. QLQ-C30 comprised of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects).	1 month

Collaborators and Investigators

• Sponsor: Ahlia University
• Collaborators: Cairo University
• Investigators: Study Director: Sayed A Tantawy, Cairo university

Publications and helpful links

General Publications

• Tantawy SA, Abdelbasset WK, Nambi G, Kamel DM. Comparative Study Between the Effects of Kinesio Taping and Pressure Garment on Secondary Upper Extremity Lymphedema and Quality of Life Following Mastectomy: A Randomized Controlled Trial. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419847276. doi: 10.1177/1534735419847276.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2017
• Primary Completion (Actual): June 7, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: December 25, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Postoperative Complications; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: Cairo University (Other Identifier: Cairo University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No