Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy
Comparative Effects of Kinesio Tapping and Pressure Garments on Upper Extremity Lymphedema, Functional Disability and Quality of Life After Mastectomy
1 other identifier
interventional
30
1 country
1
Brief Summary
To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 25, 2021
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedMarch 9, 2023
March 1, 2023
1.2 years
February 20, 2023
March 7, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Girth Measurement (with Tape)
The tape was used to assess the limb diameter.
3 weeks
Handgrip strength was evaluated using a dynamometer
A dynamometer was used to assess muscle strengthening and hand grip strengthening
3 weeks
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
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
Study Arms (2)
Effect of kinesio taping on upper limb lymphedema
EXPERIMENTALKinesio taping was applied 2 times a week for 3 weeks to the KT group. KT improves fluid movement by widening the distance between connective tissues like skin and fascia,fascia and muscles and skin and muscles.
Effect of pressure garments on upper limb lymphedema
ACTIVE COMPARATORPG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Active disease leading to swelling
- Patients on medications, especially diuretics
- Allergy
- Infection
- Pregnancy
- Heart and kidney diseases
- Bilateral lymphedema
- Skin diseases
- Cellulitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lahore General Hospital
Lahore, Punjab Province, 54000, Pakistan
Related 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.
PMID: 29520533BACKGROUNDOliveira 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.
PMID: 29304140BACKGROUNDMunoz-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 proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial. BMC Cancer. 2020 Nov 9;20(1):1074. doi: 10.1186/s12885-020-07558-x.
PMID: 33167921RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
dania sardar
Riphah IU
- STUDY DIRECTOR
Sobia Kanwal
Riphah IU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 9, 2023
Study Start
December 25, 2021
Primary Completion
March 1, 2023
Study Completion
March 30, 2023
Last Updated
March 9, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share