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

Not Applicable

Not yet recruiting

• Conditions: Lymphedema; Breast Cancer Stage II

• Registration Number: NCT06808178
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study Start: 2025-02-01
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
girth measurment	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."
handgrip strength	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 Outcome Measures

Name	Time	Method
shoulder pain and disability index	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.
quality of life questionnaire	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

Trial Locations

Locations (2)

Cairo -Beni-Suif University Hospital; 🇪🇬 Giza, Cairo, Egypt

Cairo University Hospital; 🇪🇬 Cairo, القاهرة, Egypt