Effects of Electrical Stimulation on Blood Circulation and Sensibility Tactil in Lymphadenectomy

University of Sao Paulo

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Neurodyn High Volt Model (IBRAMED); Procedure: high voltage electrical stimulation - axillary lymphadenectomy; Procedure: High voltage electrical stimulation - ( healthy women )

Study type: Interventional

Funder types: Other

Identifiers

NCT01893957

U1111-1143-1024

Details and patient eligibility

About

The aim of this study is to investigate the influence of electrical stimulation at the speed of blood circulation and tactile sensitivity of the arms of women who underwent axillary dissection for breast cancer.

Full description

Introduction: the surgical treatment of breast cancer, especially axillary lymphadenectomy (AL), can cause blood circulatory changes, also partial or total lesion of the sensory nerve intercostobrachial, often causing anesthesia or hypoesthesia in the corresponding dermatome ipsilateral upper limb surgery. Objective: to investigate the influence of high voltage electrical stimulation (HVES) in the in the blood flow and tactile sensitivity in nerve path intercostobrachial of women undergoing AL. Methodology: sample of 30 volunteers, aged between 40 and 60 years, divided into two equal groups (n = 15): women with axillary dissection for breast cancer undergoing therapeutic procedure (GAL) and control group (CG) composed of women who did not undergoing axillary surgery. The treatment procedure consist of the application of high voltage electrical simulation for 30 minutes in both limbs twice a week over the course of seven weeks. The profile of blood flow, including speed, direction were evaluated by means of continuous wave Doppler ultrasound. The assessment of tactile sensitivity was accomplished through esthesiometer in three stages: before the start of the first therapeutic procedure, after completion of the intervention and 30 days after the end of treatment (wash-out). The data will be analyzed using descriptive statistics (ANOVA) even as the hypothesis testing of Shapiro-Wilk and if the data are not normally distributed, non-parametric tests will be used. For the analyses will be used SPSS software with critical level of 5%. The results obtained on this study aim to justify therapies for intervention with that equipment in the treatment of morbidities caused by axillary linfadenectomy.

Enrollment: 30 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women, 40 to 60 years old, with abnormal sensitivity of the ipsilateral upper limb due to Type Madden Modified Radical Mastectomy for breast cancer with axillary lymphadenectomy

Exclusion criteria

• patients undergoing other types of surgery that is not considered in the inclusion criteria, bilateral mastectomy, has a diagnosis of metastases, and skin disorders such as ulcers or erysipelas in the region (or nearby) the intercostal nerve pathway. We also excluded volunteers with some sort of cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Healthy

Experimental group

Description:

Healthy women undergoing high voltage electrical stimulation

Treatment:

Device: Neurodyn High Volt Model (IBRAMED)

Procedure: High voltage electrical stimulation - ( healthy women )

Axillary lymphadenectomy

Experimental group

Description:

Axillary lymphadenectomy volunteers undergoing to high voltage electrical stimulation

Treatment:

Device: Neurodyn High Volt Model (IBRAMED)

Procedure: high voltage electrical stimulation - axillary lymphadenectomy