Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

NCT06753175 | Completed

• 1 other identifier: P.T.REC/012/005390
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (3)

• Measuring pain intensity:

  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:

  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:

  Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).

  2 months

Study Arms (2)

Group A (CDT + Underwater Galvanic Stimulation group

EXPERIMENTAL

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; Other: Complete Decongestive Therapy (CDT):

Group B (CDT group):

ACTIVE COMPARATOR

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

Interventions

underwater galvanic stimulation by 4-cell bath DEVICE

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).

Group A (CDT + Underwater Galvanic Stimulation group

Complete Decongestive Therapy (CDT): OTHER

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).

Group A (CDT + Underwater Galvanic Stimulation group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ▪ 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.

You may not qualify if:

• ▪ Cardiac diseases.
• Patients with active cancer
• Patients with pacemakers or other implantable devices
• Patients with a history of seizures or epilepsy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Baths; carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical therapy for surgery

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: January 15, 2025
• Primary Completion: March 15, 2025
• Study Completion: May 15, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

EG (1)