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

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ClinicalTrials.gov Identifier: NCT03401086
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Dr Sayed Tantawy, Ahlia University

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Other: Kinesio Taping Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Comparison of Kinesiotaping and Pressure Garment on Old Adult Women With Secondary Upper Extremity Lymphedema Following Mastectomy: A Randomized Controlled Trial
Actual Study Start Date : February 4, 2017
Actual Primary Completion Date : June 7, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Study group
Kinesio Taping
Other: Kinesio Taping
Kinesio Taping

No Intervention: Control group
No intervention



Primary Outcome Measures :
  1. Limb circumference [ Time Frame: 1 month ]
    The upper Limbs circumferences were measured by using a tape measure with the patient in prone lying position.


Secondary Outcome Measures :
  1. Shoulder Pain and Disability Index [ Time Frame: 1 month ]
    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.

  2. Hand grip strength [ Time Frame: 1 month ]
    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.

  3. Quality of life [ Time Frame: 1 month ]
    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).



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women with breast cancer lymphedema after mastetctomy
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401086


Locations
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Egypt
Dr Dalia Kamel
Giza, Egypt
Dr Sayed Tanatwy
Giza, Egypt
Sponsors and Collaborators
Ahlia University
Cairo University
Investigators
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Study Director: Sayed A Tantawy Cairo University

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Responsible Party: Dr Sayed Tantawy, Associate Professor, Ahlia University
ClinicalTrials.gov Identifier: NCT03401086     History of Changes
Other Study ID Numbers: Cairo University
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes