Different Level of ECSWT in Post Mastectomy Lymphedema

February 23, 2024 updated by: Christina Sabry, Cairo University

Different Levels of Energy of Extracorporeal Shock Wave Therapy in Post Masrectomy Lymphedema

to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt, 12612
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Criteria of selecting the patients from hospital included the following;

  1. Their ages ranged from 30 to 50 years.
  2. All patients were examined carefully by physician before the study procedure.
  3. All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema.
  4. They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention.
  5. Only ambulant subjects without any aides will be selected.
  6. The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ).
  7. All patients will be medically stable.
  8. Each patient will sign a consent form which in that insures her eligibility in the study.
  9. All patients were treated by the same doctor and physiotherapist.

Exclusion Criteria:

  • The subjects had been excluded from the study if they met one of the following criteria;

    1. The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases.
    2. Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded.
    3. The patients had neurological or orthopedic problems, and diabetes.
    4. Patients with primary lymphedema.
    5. Cardiopulmonary disease which decrease the patient activites.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Shockwave
Device: Shockwave
CDT and different dose of shockwave
Other Names:
  • CDT
Experimental: Group B
Shockwave
Device: Shockwave
CDT and different dose of shockwave
Other Names:
  • CDT
Placebo Comparator: Group C
CDT
Other: CDT
CDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymphedema volume
Time Frame: two months
tape measurment
two months
skin thickness of the arm
Time Frame: two months
ultrasonography
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Haytham M Elhafez, Faculty of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/012/003318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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