Clinical trial NCT05762224: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema of Upper Limb
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Girth Measurement (with Tape)
timeFrame: 3 weeks
measure: Handgrip strength was evaluated using a dynamometer
timeFrame: 3 weeks
measure: The quality of life was assessed by a cancer-specific questionnaire (EORTC QLQ-C30)
timeFrame: 3 weeks
measure: Disabilities of arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore General Hospital
state: Punjab
Study officials:
affiliation: Riphah IU
name: dania sardar
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah IU
name: Sobia Kanwal
role: STUDY_DIRECTOR
References:
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.
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.
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.