EFFECT of KINESIO TAPING and LASER THERAPY in PATIENT with LYMPHEDEMA on GIRTH MEASUREMENT

NCT ID: NCT06808178

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-09-01

Brief Summary

find out the difference in the effect of kinesio taping and low level laser therapy on 66 patients with post mastectomy lymphedema as regards the following outcomes:

1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire.

Detailed Description

60 females with BCRL will be recruited in this study for 4 weeks , their age ranged from 400 to 55 years old with stege 1,2 lymphedema and randomly divided into 3 equal groups: 2) study group (A) include 20 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices 3) study group (B) include 20 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices 4) study group (C) include 20 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices regards the following outcomes:

1.girth measurement between the upper limbs 2.) SPADI 3) hand grip strength 4)the quality of life by cancer specific questionnaire.

Conditions

Lymphedema; Breast Cancer Stage II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

study group (A) include 20 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices

Group Type: EXPERIMENTAL

kinesio taping

Intervention Type: OTHER

• the material used is 100%acrylic,latex free and heat activated with 10-15% stretch.
• It is made of 100% cotton to allow quickening of the drying process.
• Ability to stretch to 120-140% of its original length
• Recoil back to the anchor that is applied without stretch
• Heat-activated adhesive
• Hypoallergenic dyes that make the tape safe for most users
• Latex-free
• Drying time after being wet is about 5-10 minutes
• Can be worn for several days

Group B

study group (B) include 20 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices

Group Type: EXPERIMENTAL

Low Level Laser Therapy

Intervention Type: DEVICE

The device has the following treatment parametes :

• Maximum average power > 500 milli watts
• Wave length combined (904-808) nm
• Maximum repition rate (1-2000) Hz
• Energy density : 4:6 J per cm per session

Group C

study group (C) include 20 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices

Group Type: EXPERIMENTAL

Low Level Laser Therapy

Intervention Type: DEVICE

The device has the following treatment parametes :

• Maximum average power > 500 milli watts
• Wave length combined (904-808) nm
• Maximum repition rate (1-2000) Hz
• Energy density : 4:6 J per cm per session

kinesio taping

Intervention Type: OTHER

• the material used is 100%acrylic,latex free and heat activated with 10-15% stretch.
• It is made of 100% cotton to allow quickening of the drying process.
• Ability to stretch to 120-140% of its original length
• Recoil back to the anchor that is applied without stretch
• Heat-activated adhesive
• Hypoallergenic dyes that make the tape safe for most users
• Latex-free
• Drying time after being wet is about 5-10 minutes
• Can be worn for several days

Interventions

Low Level Laser Therapy

The device has the following treatment parametes :

• Maximum average power > 500 milli watts
• Wave length combined (904-808) nm
• Maximum repition rate (1-2000) Hz
• Energy density : 4:6 J per cm per session

Intervention Type: DEVICE

kinesio taping

• the material used is 100%acrylic,latex free and heat activated with 10-15% stretch.
• It is made of 100% cotton to allow quickening of the drying process.
• Ability to stretch to 120-140% of its original length
• Recoil back to the anchor that is applied without stretch
• Heat-activated adhesive
• Hypoallergenic dyes that make the tape safe for most users
• Latex-free
• Drying time after being wet is about 5-10 minutes
• Can be worn for several days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• persistence of lymphedema following mastectomy or breast conservative surgery for at least 3 months

• minimum volume difference of 200 mL or an average difference in arm circumference of 2 cm or 10% between healthy and affected limbs.
• Femal with unilateral lymphedema from 40 to 55 years old

Exclusion Criteria

• • Any disease lead to swelling

• Medication especially diuretics
• allergy
• infection
• pregnancy
• heart band kidney disease
• bilateral lymphedema
• skin disease
• chronic inflammatory disease

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Awad Ramadan Elkholy

Lecturer of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MERIT MAGDY ZAKI, physiotherapist

Role: PRINCIPAL_INVESTIGATOR

beni suif university

SHERIN HASSAN MEHANI, Professor of Physical therapy

Role: STUDY_CHAIR

beni suif university

MAHMOUD AWD ELKHOLY, Lecturer of physical therapy

Role: STUDY_DIRECTOR

beni suif university

Locations

Cairo University Hospital

Cairo, Cairo Governorate, Egypt

Cairo -Beni-Suif University Hospital

GIZA, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Mahmoud awd elkholy, lecturer of physical therapy

Role: CONTACT

elkholym774@gmail.com

00201125746573

SHERIN HASSAN MEHANI, Professor of Physical therapy

Role: CONTACT

00201003378217

Facility Contacts

mahmoud awd elkholy, lecturer

Role: primary

elkholym774@gmail.com

00201125746573

mahmoud awd El-din

Role: primary

Other Identifiers

FMBSUREC/02012024/Zaki

Identifier Type: -

Identifier Source: org_study_id