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

NCT ID: NCT03401086

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-04

Study Completion Date

2017-11-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Breast Cancer Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Study group

Kinesio Taping

Group Type ACTIVE_COMPARATOR

Kinesio Taping

Intervention Type OTHER

Kinesio Taping

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kinesio Taping

Kinesio Taping

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Ahlia University

OTHER

Sponsor Role lead

Responsible Party

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Dr Sayed Tantawy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayed A Tantawy

Role: STUDY_DIRECTOR

Cairo University

Locations

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Dr Dalia Kamel

Giza, , Egypt

Site Status

Dr Sayed Tanatwy

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 31068019 (View on PubMed)

Other Identifiers

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Cairo University

Identifier Type: -

Identifier Source: org_study_id

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