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

NCT06808178 | Not Yet Recruiting DMC

• 1 other identifier: FMBSUREC/02012024/Zaki
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphedema; Breast Cancer Stage II

Keywords

laser taping

Outcome Measures

Primary Outcomes (2)

• girth measurment

  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

  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 Outcomes (2)

• shoulder pain and disability index

  4 weeks

• quality of life questionnaire

  4 weeks

Study Arms (3)

group A

EXPERIMENTAL

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

Other: kinesio taping

Group B

EXPERIMENTAL

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

Device: Low Level Laser Therapy

Group C

EXPERIMENTAL

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

Device: Low Level Laser Therapy; Other: kinesio taping

Interventions

Low Level Laser Therapy 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 B; Group C

kinesio taping 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 C; group A

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Cairo University Hospital

Cairo, Cairo Governorate, 11865, Egypt

Location

Cairo -Beni-Suif University Hospital

GIZA, Cairo Governorate, 11865, Egypt

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• MERIT MAGDY ZAKI, physiotherapist

  beni suif university

  PRINCIPAL INVESTIGATOR

• SHERIN HASSAN MEHANI, Professor of Physical therapy

  beni suif university

  STUDY CHAIR

• MAHMOUD AWD ELKHOLY, Lecturer of physical therapy

  beni suif university

  STUDY DIRECTOR

Central Study Contacts

Mahmoud awd elkholy, lecturer of physical therapy

CONTACT

00201125746573; elkholym774@gmail.com

SHERIN HASSAN MEHANI, Professor of Physical therapy

CONTACT

00201003378217

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Model Details: 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

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-12

Locations

EG (2)