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

Breast Cancer Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401086
• Other study ID #: Cairo University
• Status: Completed
• Phase: N/A
• First received: December 25, 2017
• Last updated: January 9, 2018
• Start date: February 4, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2018
• Source: Ahlia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 1, 2017
• Est. primary completion date: June 7, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

Intervention

Other:
• Kinesio Taping
Kinesio Taping

Locations

Country	Name	City	State
Egypt	Dr Dalia Kamel	Giza
Egypt	Dr Sayed Tanatwy	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Ahlia University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb circumference	The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.	1 month
Secondary	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
Secondary	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
Secondary	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