Lymphedema
Conditions
Keywords
Mastectomy
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.
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).
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring pain intensity: | 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: | 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: | 2 months | Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL). |
Countries
Egypt
Outcome results
None listed