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

U

University of Sao Paulo

Status

Unknown

Conditions

Breast Cancer

Treatments

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

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)

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

Trial contacts and locations

1

Loading...

Central trial contact

Elaine C Guirro, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems