- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06808178
EFFECT OF KINESIO TAPING AND LASER THERAPY IN PATIENT WITH LYMPHEDEMA ON GIRTH MEASUREMENT (LYMPHEDEMA)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11865
- Cairo University Hospital
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GIZA, Cairo Governorate, Egypt, 11865
- Cairo -Beni-Suif University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
|
|
|
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 :
|
|
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 device has the following treatment parametes :
|
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMBSUREC/02012024/Zaki
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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