Clinical trial NCT02769052: TENS Self-applied in the Complementary Treatment of Deep Endometriosis
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) Self-applied as Complementary Treatment for Pain and Its Impact on Quality of Life and Sexuality of Women With Deep Endometriosis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
dyspareunia
physical therapy
sexuality
transcutaneous electrical nerve stimulation
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women at reproductive age;
* 18 and 50 years;
* diagnosis of deep endometriosis (cul-de-sac and intestinal lesions);
* using hormonal treatment at least 3 months;
* persistence of chronic pelvic pain and/or dyspareunia.

Exclusion Criteria:

* Women with decreased skin sensitivity;
* pregnant women;
* women with pacemaker implants;
* cutaneous hypersensitivity (allergic reactions to gel or electrode);
* women with epilepsy;
* cardiac (cardiac arrhythmia);
* osteosynthesis in the application place;
* a solution of discontinuity of the skin;
* malignant tumors;
* acute inflammatory disease;
* other gynecological associated pathologies;
* a cognitive deficiency that precludes the understanding of instruments and/or instructions for self-applied of TENS.

Primary outcomes:
measure: Improvement of Pelvic Pain
timeFrame: up to one year
measure: Improvement of Pain during the relation
timeFrame: up to one year
Secondary outcomes:
measure: Improvement of Quality of life
timeFrame: up to one year
measure: Improvement of Sexuality
timeFrame: up to one year
measure: Improvement of The global pain
timeFrame: up to one year
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Gynecology Hospital
state: São Paulo
Study officials:
affiliation: University of Campinas
name: Ticiana AA Mira, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas
name: Cristina L Benetti-Pinto, PhD
role: STUDY_CHAIR
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