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

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

Study Overview

• Status: Recruiting
• Conditions: Lymphedema of Upper Limb
• Intervention / Treatment: Other: Effect of kinesio taping on upper limb lymphedema

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatima Tariq, m-phil; Phone Number: 03338789778; Email: fatima.tariq@riphah.edu.pk
• Study Contact Backup: Name: sobia kanwal, DPT; Phone Number: 03028498496; Email: sobiak_28@hotmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Lahore General Hospital
      • Principal Investigator: Dania Sardar, m phil
      • Sub-Investigator: Sobia Kanwal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effect of kinesio taping on upper limb lymphedema; 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.	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; Other Names: USE of Pressure Garments with coventional PT
Active Comparator: Effect of pressure garments on upper limb lymphedema; PG group received pressure garments ( 20-60 mmHg)for at least 15 to 18 hours per day for 3 weeks.	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; Other Names: USE of Pressure Garments with coventional PT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: dania sardar, Riphah IU; Study Director: Sobia Kanwal, Riphah IU

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: REC/RCR & AHS/22/0547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No