Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

NCT ID: NCT06753175

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

underwater galvanic stimulation by 4-cell bath

Intervention Type 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):

Intervention Type 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 B (CDT group):

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

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Gamal Fawzy El-Sayed

Lecturer of Physical therapy for surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/005390

Identifier Type: -

Identifier Source: org_study_id

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