Outpatient clinic, Faculty of Physical Therapy, Cairo university
Giza, Dokki, 11432, Egypt
NCT Number: NCT05761353
Statement of the problem:
The problem will be stated in a questionary form:
"Which will be more effective endermologie or negative pressure therapy in reducing limb circumference and volume in postmastectomy lymphedema?".
Hypothesis:
It will be hypothesized that:
There is no significant difference between endermologie and negative pressure therapy in reducing circumference and limb volume in post mastectomy lymphedema.
Looking for future studies?
Notify Me40 year–60 year
Female
Interventional
Not applicable
Giza, Dokki, 11432, Egypt
Subject:
Sixty- eight women treated for unilateral breast cancer with secondary upper limb lymphedema post mastectomy will participate in this study. Their ages will be ranged from 40 to 60 years, they will be free from any other diseases that will affect or influence the results and the participants will be selected from National Cancer Institute and randomly distributed into two equal groups in number.
Study design:
In this study the patients will be randomly assigned into two groups equal in number (34 patients for each group).
Inclusion criteria
The subject selection will be according to the following criteria:
Exclusion criteria
The potential participants will be excluded if they meet one of the following criteria:
Equipment:
The study equipment's will be divided into measurement and therapeutic equipment and tools:
1: Measurement equipment
1(a):Limb volume measurement:
This will be performed by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as:
V=h (c12+c1c2+c22 )/12π, where V is the volume of the segment, c1 and c2 are the circumferences at the ends of the segment, and h is the distance between them.
Measurement of limb volume measurement will be conducted pre-treatment and after treatment course (6 weeks).
The study group will receive 18 sessions by Endermologie system ( used to decrease postmastectomy lymphedema for group (A), three sessions per week for six weeks.
Each session was 30 minutes at the posterior thorax, upper arm, forearm and the hand.
2.b. Negative pressure therapy:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group A will receive -18 sessions by Endermologie system used to decrease postmastectomy lymphedema for group (A), three sessions per week for six weeks.
Each session was 30 minutes at the posterior thorax, upper arm, forearm and the hand.
-In addition to physical therapy program (active range of motion and elevation); hygiene and skin care
Group B will receive negative pressure therapy with
Time frame: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment
Measuring Disability of the arm, shoulder and hand will be carried out by using Quick-DASH questionnaire
Time frame: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb volume and decrease of lymph-edema
Limb volume measurement will be carried out by by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as:
V=h (c1+c1c2+c2 )/12π
Cairo University
Other
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