Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy

Lymphedema of Upper Limb Clinical Trial

Official title:

Comparative Effects of Kinesio Tapping and Pressure Garments on Upper Extremity Lymphedema, Functional Disability and Quality of Life After Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762224
• Other study ID #: REC/RCR & AHS/22/0547
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2023
• Source: Riphah International University
• Contact: Fatima Tariq, m-phil
• Phone: 03338789778
• Email: fatima.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy.

Description:

The study's primary goal was to find the effects of Kinesio taping and compression garments on the upper extremity lymphedema following mastectomy. This aim was realized through the current study results, the findings of the current study showed that Kinesio taping and compression garments were equally effective on the upper extremity lymphedema following mastectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• • Age (45 years-75 years)
• Patients with edema after 1-year mastectomy
• Unilateral lymphedema
• Arm circumference change (Arm circumference unilateral than 2 cm or less than 8 cm in comparison with the other side was included)
• Functional disability or limited movements (shoulder, arm, and hand)

Exclusion Criteria:

• • Active disease leading to swelling
• Patients on medications, especially diuretics
• Allergy
• Infection
• Pregnancy
• Heart and kidney diseases
• Bilateral lymphedema
• Skin diseases
• Cellulitis.

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Upper Limb

Intervention

Other:
• Effect of kinesio taping on upper limb lymphedema
Group A received Kinesio taping 2 times a week for 3 weeks to reduce lymphedema and Group B received pressure garments(20-60 mm Hg) for at least 15 to 18 hours per day for 3 weeks

Locations

Country	Name	City	State
Pakistan	Lahore General Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Bao T, Iris Zhi W, Vertosick EA, Li QS, DeRito J, Vickers A, Cassileth BR, Mao JJ, Van Zee KJ. Acupuncture for breast cancer-related lymphedema: a randomized controlled trial. Breast Cancer Res Treat. 2018 Jul;170(1):77-87. doi: 10.1007/s10549-018-4743-9. Epub 2018 Mar 8. — View Citation

Munoz-Alcaraz MN, Perula-de-Torres LA, Serrano-Merino J, Jimenez-Vilchez AJ, Olmo-Carmona MV, Munoz-Garcia MT, Bartolome-Moreno C, Olivan-Blazquez B, Magallon-Botaya R. Efficacy and efficiency of a new therapeutic approach based on activity-oriented propr — View Citation

Oliveira MMF, Gurgel MSC, Amorim BJ, Ramos CD, Derchain S, Furlan-Santos N, Dos Santos CC, Sarian LO. Long term effects of manual lymphatic drainage and active exercises on physical morbidities, lymphoscintigraphy parameters and lymphedema formation in patients operated due to breast cancer: A clinical trial. PLoS One. 2018 Jan 5;13(1):e0189176. doi: 10.1371/journal.pone.0189176. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Girth Measurement (with Tape)	The tape was used to assess the limb diameter.	3 weeks
Primary	Handgrip strength was evaluated using a dynamometer	A dynamometer was used to assess muscle strengthening and hand grip strengthening	3 weeks
Primary	The quality of life was assessed by a cancer-specific questionnaire (EORTC QLQ-C30)	The EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the physical, psychological, and social well-being of cancer patients. The EORTC QLQ-C30 was proven to be useful and valid in measuring the quality of life in patients with advanced illness in this investigation	3 weeks
Primary	Disabilities of arm, Shoulder and Hand Questionnaire (DASH)	The function was assessed using the validated 30-item Quick-Disabilities of Arm, Shoulder, and Hand (Quick DASH) assessment. Respondents are asked to score their capacity to undertake specific activities (such as heavy housework or carrying a shopping bag); the degree of interference with regular social activities, work activities, sleep impairment, pain ratings, and altered sensations	3 weeks