Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

Cairo University (CU)

Status: Completed

Conditions: Lymphedema

Treatments: Other: Complete Decongestive Therapy (CDT):; Device: underwater galvanic stimulation by 4-cell bath

Study type: Interventional

Funder types: Other

Identifiers

NCT06753175

P.T.REC/012/005390

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group A (CDT + Underwater Galvanic Stimulation group

Experimental group

Description:

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.

Treatment:

Device: underwater galvanic stimulation by 4-cell bath

Other: Complete Decongestive Therapy (CDT):

Group B (CDT group):

Active Comparator group

Description:

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