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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.
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 )/12Ï€, 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).
(b): Measuring Disability of the arm, shoulder and hand by: .Quick DASH questionnaire (Disability of the arm, shoulder, and hand).
Therapeutic equipment :
2. a. Endermologie: endermologie therapy will be three sessions per week for six weeks (total 18 sessions).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (endermologie group) | Experimental | This group includes 34 patients who will receive 30 min Endermologie 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks. |
|
| Group B (Negative pressure therapy group) | Experimental | This group includes34 patients who will receive 30min negative pressure therapy 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endermologie | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring Disability of the arm, shoulder and hand | Measuring Disability of the arm, shoulder and hand will be carried out by using Quick-DASH questionnaire | Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment |
| Limb volume measurement | 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 )/12Ï€ | 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 |
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Inclusion Criteria:
Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rayda M Mohamed | Cairo Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic, Faculty of Physical Therapy, Cairo university | Giza | Dokki | 11432 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2022 | Mar 4, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Negative pressure therapy | Device | Group B will receive negative pressure therapy with
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