Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema

NCT05761353 | Completed

• 1 other identifier: P.T.REC/012/003744
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Lymphedema

Outcome Measures

Primary Outcomes (2)

• 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 )/12π

  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

Study Arms (2)

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.

Device: Endermologie

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

Device: Negative pressure therapy

Interventions

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

Group A (endermologie group)

Negative pressure therapy DEVICE

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

Group B (Negative pressure therapy group)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo university

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Rayda M Mohamed

  Cairo Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 9, 2023
• Study Start: June 29, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 30, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

EG (1)