Clinical trial NCT01893957: Effects of Electrical Stimulation on Blood Circulation and Sensibility Tactil in Lymphadenectomy
Official title: Evaluation of the Effects of High Voltage Electrical Stimulation in the Floe Blood and Tactile Sensitivity of Women Undergoing Axillary Lymphadenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
physical therapy
electrical stimulation
tactile sensitivity
flow blood
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Tactile sensitivity
timeFrame: 2 years
Secondary outcomes:
measure: Blood flow velocity
timeFrame: 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Medical School of Ribeirão Preto
state: São Paulo
Study officials:
References: