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NCT Number: NCT06808178

EFFECT OF KINESIO TAPING AND LASER THERAPY IN PATIENT WITH 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.

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Key information

Conditions

Lymphedema Breast Cancer Stage II Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospital, Cairo, Cairo Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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."

  2. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: LYMPHEDEMA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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