TENS Self-applied in the Complementary Treatment of Deep Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Objective: to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation
      (TENS) self-applied for the treatment of pain and the impact of this therapy on quality of
      life and sexuality of women with deep endometriosis.
    

Detailed description: 
      -  Women will be selected to participate in the study between June 2016 to March 2018, from
           medical records research and routine queries in Endometriosis clinic of the Gynecology's
           Hospital of University of Campinas (UNICAMP) and the clinic of Gynecology (Endometriosis
           routine queries) of the Hospital of University of São Paulo (USP). All women will
           respond to the Check List for inclusion in the study and will sign an informed consent
           form.

        -  The women selected will be randomized into two distinct groups: follow-up/treatment -
           control group (CG) composed of two phases of 8 weeks each or treatment group (TG)
           consists of one phase of 8 weeks. The randomization will be through sealed brown
           envelopes, whose numerical sequence will be generated by computer programming in
           Statistical Analysis System (SAS), held by a person not participating in the study. Once
           allocated, all women respond to a clinical and socio-demographic questionnaire, Visual
           analog scale; Deep Dyspareunia scale; Diagram of Location and characterization of Pain;
           Endometriosis Health Profile (EHP-30); Female Sexual Function Index pre-and
           post-treatment. In addition, the woman will fill a daily control of pain.

      All procedures of the study will be carried out by the same researcher, to enforce the search
      protocol. After the end of the collection, all data will be entered in the Excel program for
      Windows and conferred for a second digitizer.

        -  The sample size calculation was based on the pilot study developed by Mira et al. (2015)
           whereas the use of the TENS for relief of chronic pelvic pain and deep dyspareunia
           generated by endometriosis, whose pre-and post-treatment discomfort was assessed by
           Visual analog scale (EVA). The number of women in this study was of 22 women divided
           into two treatment groups. Applied for the calculation of sample size, the t test for
           independent variables to the study cited and given a power of test 90% and significance
           level of 5%, the sample size obtained was of 24 patients in total. Considering the
           following loss of 20%, the total number shall be 29 women, divided into two groups:
           follow-up/treatment group (n = 15) and treatment/monitoring group (n = 14). For better
           quantification of all the variables involved, we will seek ideally a total of 80 women,
           divided into two groups (n = 40).

        -  The data obtained will be described by mean ± standard deviation. The results will be
           tested for normal distribution using the Shapiro-Wilk test. For analysis of the second
           sample groups, features will be used the Fisher exact test. For comparison of means
           obtained from scales and questionnaires, pre-and post-intervention, t-test will be used
           or non-parametric analog, for each variable, previously cited. The comparison of
           variables between groups will be analyzed by t test or nonparametric analog.
           Significance will be considered through the value p <.05. The data will be analyzed by
           intention to treat. The software used for statistical analysis SAS version 9.2.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention type(s): Device
Intervention description(s): Electrotherapy through self-applied device .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometriosis; dyspareunia; physical therapy; sexuality; transcutaneous electrical nerve stimulation