Skip to content

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

Evaluation of the Effects of High Voltage Electrical Stimulation in the Floe Blood and Tactile Sensitivity of Women Undergoing Axillary Lymphadenectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01893957
Enrollment
30
Registered
2013-07-09
Start date
2012-08-31
Completion date
2013-09-30
Last updated
2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, physical therapy, electrical stimulation, tactile sensitivity, flow blood

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREhigh voltage electrical stimulation - axillary lymphadenectomy

Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm.

PROCEDUREHigh voltage electrical stimulation - ( healthy women )

Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm.

DEVICENeurodyn High Volt Model (IBRAMED)

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tactile sensitivity2 yearsWill be used Estesiômetro Semmes-Weinstein (SORRY®) to evaluate the tactile sensibility in dermatomes corresponding on the medial and superior-posterior arm.

Secondary

MeasureTime frameDescription
Blood flow velocity2 yearsThe evaluation of the peripheral arterial and venous flow in the upper limbs will be accomplished through the equipment ultrasound Doppler (Nicolet Vascular Versalab SE®), and the collection site will be in the antecubital fossa, of the brachial artery and brachial vein.

Countries

Brazil

Contacts

Primary ContactElaine C Guirro, Ph.D
ecguirro@fmrp.usp.br551636024584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026