Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

September 13, 2025 updated by: Aya Gamal Fawzy El-Sayed, Cairo University

Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema Post Mastectomy.

Sixty female patients with lymphedema post mastectomy, aged 30-55 years, will be selected from Minia Oncology Institute. The participants will be randomly distributed into two equal groups:

  1. Group A (CDT + Underwater Galvanic Stimulation group):

    This group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with CDT for 2 months (3times/week) in addition to their medical treatment.

  2. Group B (CDT group):

This group includes 30 patients who will receive only CDT for 2 months (3times/week) in addition to their medical treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
      • Giza, Egypt
        • 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:

  • ▪ Female patients with lymphedema post mastectomy

    • Aged 30-55 years
    • No history of cardiac or renal disease
    • No contraindications to electrotherapy
    • All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

  • ▪ Cardiac diseases.

    • Patients with active cancer
    • Patients with pacemakers or other implantable devices
    • Patients with a history of seizures or epilepsy

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 (CDT + Underwater Galvanic Stimulation group
This group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with CDT for 2 months (3times/week) in addition to their medical treatment.
Device: underwater galvanic stimulation by 4-cell bath

Underwater Galvanic Stimulation:

  • Equipment: 4-cell bath
  • Procedure: Patients will immerse their affected limbs in the 4-cell bath. Electrical stimulation will be applied at a frequency of 15 Hz and intensity of 20 mA for 20 minutes, 3 times per week (Han et al. 2020).
Other: Complete Decongestive Therapy (CDT):

Complete Decongestive Therapy (CDT):

  • Manual Lymphatic Drainage (MLD): 60 minutes per session, 3 days per week.
  • Compression Therapy: Multilayer bandaging applied after MLD.
  • Exercise: Specific exercises performed with compression in place.
  • Skin Care: Routine skin and nail care to prevent infections (Curlett et al. 2020).
Active Comparator: Group B (CDT group):
This group includes 30 patients who will receive only CDT for 2 months (3times/week) in addition to their medical treatment.
Other: Complete Decongestive Therapy (CDT):

Complete Decongestive Therapy (CDT):

  • Manual Lymphatic Drainage (MLD): 60 minutes per session, 3 days per week.
  • Compression Therapy: Multilayer bandaging applied after MLD.
  • Exercise: Specific exercises performed with compression in place.
  • Skin Care: Routine skin and nail care to prevent infections (Curlett et al. 2020).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring pain intensity:
Time Frame: 2 months
The Visual Analogue Scale (VAS) will be employed. This 10cm line, marked from "no pain"(zero) to "worst pain (10) imaginable," will be used to represent the pain continuum. Patients will be guided on how to interact with the VAS scale, ensuring clarity and ease of use.
2 months
Measuring the volume of a patient's upper limb:
Time Frame: 2 months

Essential tools such as a flexible tape measure, marker pen or pencil, and a recording sheet will be collected. Measurements will be taken at specific anatomical landmarks every 4 cm, including the wrist, the midpoint of the forearm, and where the upper arm meets the shoulder. The tape measure will be applied snugly around the limb without tightening, ensuring consistency in tension. Both the affected and non-affected limbs will be measured for comparison, with a more than 10% volume increase indicating potential edem. Circumference measurements will be recorded to the nearest 0.1 cm without indenting the skin.

The frustum of a cone formula will be used to estimate each arm segment's volume, with repeated measures for ongoing assessment.
2 months
Improvement in quality of life:
Time Frame: 2 months
Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
2 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

January 15, 2025

Primary Completion (Actual)

March 15, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 13, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005390

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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