Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

Browse trials for

• Lymphedema 560

Keywords

• Mastectomy

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 403 interventional studies indexed under Lymphedema.

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Study arms

• Experimental
  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.

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

• Active comparator
  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.

Interventions

• Deviceunderwater 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).

• OtherComplete 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).

Primary outcomes

1. 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.

   Time frame: 2 months

2. 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.

   Time frame: 2 months

3. Improvement in quality of life:

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

   Time frame: 2 months