LymphedemaNCT06753175
Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.
A study testing underwater galvanic stimulation by 4-cell bath and Complete Decongestive Therapy (CDT): in people with Lymphedema, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- underwater galvanic stimulation by 4-cell bath and Complete Decongestive Therapy (CDT):
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ▪ 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.
Who cannot join
- ▪ Cardiac diseases.
- Patients with active cancer
- Patients with pacemakers or other implantable devices
- Patients with a history of seizures or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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 B (CDT group):
This group includes 30 patients who will receive only CDT for 2 months (3times/week) in addition to their medical treatment.
- Conditions
- Lymphedema
- Being tested
- underwater galvanic stimulation by 4-cell bath, Complete Decongestive Therapy (CDT):
- Keywords
- Mastectomy
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
underwater galvanic stimulation by 4-cell bathDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Improvement in quality of life:
Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start15 Jan 2025
- Primary completion15 Mar 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753175
- Sponsor's protocol ID
- P.T.REC/012/005390
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema Post Mastectomy.
- ClinicalTrials.gov ID
- NCT06753175
- Acronym / sponsor ID
- P.T.REC/012/005390
- Conditions
- Lymphedema
- Keywords
- Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (CDT + Underwater Galvanic Stimulation group | Experimental | Device: underwater galvanic stimulation by 4-cell bath, Other: Complete Decongestive Therapy (CDT):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 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ▪ Female patients with lymphedema post mastectomy
Key exclusion criteria (4 listed)
- ▪ Cardiac diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| underwater galvanic stimulation by 4-cell bathUnderwater 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). | Device | Group A (CDT + Underwater Galvanic Stimulation group |
| 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). | Other | Group A (CDT + Underwater Galvanic Stimulation group |
Primary outcome
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.
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.
Improvement in quality of life:
Time frame: 2 months
Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing underwater galvanic stimulation by 4-cell bath and Complete Decongestive Therapy (CDT): in people with Lymphedema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring pain intensity: (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.