Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema.

Not Applicable

Not yet recruiting

• Conditions: Lymphedema

• Registration Number: NCT06753175
• Lead Sponsor: Cairo University

Brief 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. 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

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-15
• Primary Completion: 2025-03-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measuring pain intensity:	2 months	The Visual Analogue Scale (VAS) will be employed. This 10cm line, marked from "no pain" to "worst pain 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 (Bijur \& Gallagher, 2001).
Measuring the volume of a patient's upper limb:	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 (Karges et al., 2003). The tape measure will be applied snugly around the limb without tightening, ensuring consistency in tension (Frownfelter et al, 2022). Both the affected and non-affected limbs will be measured for comparison, with a more than 10% volume increase indicating potential edema (Frownfelter et al, 2022). 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 (Karges et al., 2003; Frownfelter et al, 2022).
Improvement in quality of life:	2 months	Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL) (Monticone M et al, 2022).