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

Primary Purpose

Lymphedema of Upper Limb

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Effect of kinesio taping on upper limb lymphedema
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Upper Limb

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Lahore General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Effect of kinesio taping on upper limb lymphedema

Effect of pressure garments on upper limb lymphedema

Arm Description

Kinesio 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.

PG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks.

Outcomes

Primary Outcome Measures

Girth Measurement (with Tape)
The tape was used to assess the limb diameter.
Handgrip strength was evaluated using a dynamometer
A dynamometer was used to assess muscle strengthening and hand grip strengthening
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
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

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
March 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05762224
Brief Title
Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy
Official Title
Comparative Effects of Kinesio Tapping and Pressure Garments on Upper Extremity Lymphedema, Functional Disability and Quality of Life After Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effect of kinesio taping on upper limb lymphedema
Arm Type
Experimental
Arm Description
Kinesio 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.
Arm Title
Effect of pressure garments on upper limb lymphedema
Arm Type
Active Comparator
Arm Description
PG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Effect of kinesio taping on upper limb lymphedema
Other Intervention Name(s)
USE of Pressure Garments with coventional PT
Intervention Description
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
Primary Outcome Measure Information:
Title
Girth Measurement (with Tape)
Description
The tape was used to assess the limb diameter.
Time Frame
3 weeks
Title
Handgrip strength was evaluated using a dynamometer
Description
A dynamometer was used to assess muscle strengthening and hand grip strengthening
Time Frame
3 weeks
Title
The quality of life was assessed by a cancer-specific questionnaire (EORTC QLQ-C30)
Description
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
Time Frame
3 weeks
Title
Disabilities of arm, Shoulder and Hand Questionnaire (DASH)
Description
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
Time Frame
3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Tariq, m-phil
Phone
03338789778
Email
fatima.tariq@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
sobia kanwal, DPT
Phone
03028498496
Email
sobiak_28@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dania sardar
Organizational Affiliation
Riphah IU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sobia Kanwal
Organizational Affiliation
Riphah IU
Official's Role
Study Director
Facility Information:
Facility Name
Lahore General Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dania Sardar, m phil
First Name & Middle Initial & Last Name & Degree
Sobia Kanwal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29520533
Citation
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.
Results Reference
background
PubMed Identifier
29304140
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.
Results Reference
background
PubMed Identifier
33167921
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 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.
Results Reference
result

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

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