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Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema

Primary Purpose

Mastectomy; Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endermologie
Negative pressure therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy; Lymphedema

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Only females will participate in the study. Patients' age was ranged between 40-60 years. All patients will suffer from post mastectomy lymphedema. All patients have a modified radical mastectomy. All patients suffer from grade II lymphedema without skin changes one year post mastectomy(as defined by the International Society of Lymphology). All patients are right-dominant hand. All patients enrolled to the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: primary lymphedema. Diabetes mellitus. Pregnancy. Recurrent cancer. Current or recent cellulitis. Current metastases. Venous thrombosis. Photosensitivity. Phlebitis in development stage. Infection. Receiving anti-coagulant treatment.

Sites / Locations

  • Outpatient clinic, Faculty of Physical Therapy, Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (endermologie group)

Group B (Negative pressure therapy group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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 )/12π

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
July 4, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05761353
Brief Title
Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
Official Title
Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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: Only females will participate in the study. Patients' age will be ranged between 40-60 years. All patients will suffer from post mastectomy lymph-edema. All patients have a modified radical mastectomy. All patients will suffer from grade II lymph edema without skin changes one year post mastectomy. All patients are right-dominant hand. All patients enrolled to the study have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: primary lymph-edema. Diabetes mellitus. Pregnancy. Recurrent cancer. Current or recent cellulitis. Current metastases. Venous thrombosis. Photosensitivity. Phlebitis in development stage. Infection. Receiving anti-coagulant treatment. 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). (b): Measuring Disability of the arm, shoulder and hand by: .Quick DASH questionnaire (Disability of the arm, shoulder, and hand). The Quick- DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do. Quick DASH scale will be conducted pre-treatment and after treatment course (6 weeks). 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: Pressure: 20-250 mm Hg. Total treatment period: six weeks. A number of sessions: 3 sessions/ week. Time of application : 30 min

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (endermologie group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (Negative pressure therapy group)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Endermologie
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Negative pressure therapy
Intervention Description
Group B will receive negative pressure therapy with Pressure: 20-250 mmHg. Total treatment period: 6weeks A number of sessions: 3sessions/ week. Time of application : 30 min In addition to physical therapy program (active range of motion and elevation); hygiene and skin care
Primary Outcome Measure Information:
Title
Measuring Disability of the arm, shoulder and hand
Description
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 function before and after treatment
Title
Limb volume measurement
Description
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
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Only females will participate in the study. Patients' age was ranged between 40-60 years. All patients will suffer from post mastectomy lymphedema. All patients have a modified radical mastectomy. All patients suffer from grade II lymphedema without skin changes one year post mastectomy(as defined by the International Society of Lymphology). All patients are right-dominant hand. All patients enrolled to the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: primary lymphedema. Diabetes mellitus. Pregnancy. Recurrent cancer. Current or recent cellulitis. Current metastases. Venous thrombosis. Photosensitivity. Phlebitis in development stage. Infection. Receiving anti-coagulant treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rayda M Mohamed
Organizational Affiliation
Cairo Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic, Faculty of Physical Therapy, Cairo university
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

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Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema

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