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Completed

NCT Number: NCT06753175

Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. 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. 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.

  3. Improvement in quality of life:

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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