EFFECT OF KINESIO TAPING AND LASER THERAPY IN PATIENT WITH LYMPHEDEMA ON GIRTH MEASUREMENT (LYMPHEDEMA)

May 10, 2026 updated by: Mahmoud Awad Ramadan Elkholy, Beni-Suef University

THE EFFECT OF KINESIO TAPING AND LOW LEVEL LASER THERAPY IN PATIENT WITH POST MASTECTOMY RELATED LYMPHEDEMA ON GIRTH MEASUREMENT

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11865
        • Cairo University Hospital
      • GIZA, Cairo Governorate, Egypt, 11865
        • Cairo -Beni-Suif University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
study group (A) include 30 females with unilateral BCRL will receive kinesio taping plus manual lymphatic drainage , exercise and advices
  • 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
Experimental: Group B
study group (B) include 30 females with unilateral BCRL will receive low level laser therapy plus manual lymphatic drainage , exercise and advices

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
Experimental: Group C
study group (C) include 30 females with unilateral BCRL will receive kinesio taping plus low level laser therapy and manual lymphatic drainage , exercise and advices
  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
girth measurment
Time Frame: 4 weeks
Measurement of arm circumference is the most commonly used technique for identifying lymphedema and is reliable for both surgical and nonsurgical upper limbs It is measured using a tape with the patient in prone lying position, with elbows straight and arms relaxed at the sides. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and mid-hand. The tape measure was put around the limb to prevent it from slacking and to ensure that there was no space in the tissue. The total circumference of the sound limb was ascertained similarly. The difference between the 2 measurements was identified using "circumference difference."
4 weeks
handgrip strength
Time Frame: 4 weeks
evaluated using a dynamometer ,The grip strength was measured with the patient in a standing position with adducted shoulder, elbow flexed at 90°, and forearm in mid position. The patient was instructed to do 3 trials with 15 seconds rest in between each, and the highest reading was reported
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder pain and disability index
Time Frame: 4 weeks
was used to assess shoulder pain and disability. It incorporates 13 items assessing 2 domains: 5 items assess pain and 8 items evaluate disability.
4 weeks
quality of life questionnaire
Time Frame: 4 weeks
was assessed by cancer-specific questionnaire (EORTC QLQ-C30). It is composed of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects). The functional scores ranged between 0 and 100, and higher scores indicated better condition. This questionnaire also included symptoms score (pain, dyspnea, fatigue, insomnia, nausea, loss of appetite, and financial problems). The symptom scores ranged from 100 to 0, and lower scores indicated better condition
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: MAHMOUD AWD ELKHOLY, Lecturer of physical therapy, beni suif university
  • Principal Investigator: MERIT MAGDY ZAKI, physiotherapist, beni suif university
  • Study Chair: SHERIN HASSAN MEHANI, Professor of Physical therapy, beni suif university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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