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

NCT03401086 | Completed DMC

• 1 other identifier: Cairo University
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (1)

• Limb circumference

  The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.

  1 month

Secondary Outcomes (3)

• Shoulder Pain and Disability Index

  1 month

• Hand grip strength

  1 month

• Quality of life

  1 month

Study Arms (2)

Study group

ACTIVE COMPARATOR

Kinesio Taping

Other: Kinesio Taping

Control group

NO INTERVENTION

No intervention

Interventions

Kinesio Taping OTHER

Kinesio Taping

Study group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: women with breast cancer lymphedema after mastetctomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ahlia University: lead
• Cairo University: collaborator

Study Sites (2)

Dr Dalia Kamel

Giza, Egypt

Location

Dr Sayed Tanatwy

Giza, Egypt

Location

Related Publications (1)

• 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.

  PMID: 31068019 DERIVED

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

Study Officials

• Sayed A Tantawy

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 17, 2018
• Study Start: February 4, 2017
• Primary Completion: June 7, 2017
• Study Completion: November 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)