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

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ClinicalTrials.gov Identifier: NCT01893957
Recruitment Status : Unknown
Verified July 2013 by Elaine Caldeira de Oliveira Guirro, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : July 9, 2013
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Elaine Caldeira de Oliveira Guirro, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: high voltage electrical stimulation - axillary lymphadenectomy Procedure: High voltage electrical stimulation - ( healthy women ) Device: Neurodyn High Volt Model (IBRAMED) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of High Voltage Electrical Stimulation in the Floe Blood and Tactile Sensitivity of Women Undergoing Axillary Lymphadenectomy
Study Start Date : August 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy
Healthy women undergoing high voltage electrical stimulation
Procedure: High 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.

Device: Neurodyn High Volt Model (IBRAMED)
Experimental: Axillary lymphadenectomy
Axillary lymphadenectomy volunteers undergoing to high voltage electrical stimulation
Procedure: high 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.

Device: Neurodyn High Volt Model (IBRAMED)



Primary Outcome Measures :
  1. Tactile sensitivity [ Time Frame: 2 years ]
    Will be used Estesiômetro Semmes-Weinstein (SORRY®) to evaluate the tactile sensibility in dermatomes corresponding on the medial and superior-posterior arm.


Secondary Outcome Measures :
  1. Blood flow velocity [ Time Frame: 2 years ]
    The 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.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893957


Contacts
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Contact: Elaine C Guirro, Ph.D 551636024584 ecguirro@fmrp.usp.br

Locations
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Brazil
Medical School of Ribeirão Preto Recruiting
Ribeirão Preto, São Paulo, Brazil, 14049-900
Contact: Elaine C Guirro, Ph. D    551636024584    ecguirro@fmrp.usp.br   
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Elaine Caldeira de Oliveira Guirro, PhD, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01893957    
Other Study ID Numbers: U1111-1143-1024
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013
Keywords provided by Elaine Caldeira de Oliveira Guirro, University of Sao Paulo:
breast cancer
physical therapy
electrical stimulation
tactile sensitivity
flow blood
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases