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TENS Self-applied in the Complementary Treatment of Deep Endometriosis (tici_mira)

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ClinicalTrials.gov Identifier: NCT02769052
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ticiana Aparecida Alves de Mira, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Endometriosis Device: Transcutaneous Electrical Nerve Stimulation (TENS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Follow-up/Treatment - Control Group
Composed of two phases of 8 weeks each (follow-up - treatment). The treatment using the self-applied Transcutaneous Electrical Nerve Stimulation (TENS) will prescribe with daily application, twice a day for 20 minutes each application.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy through self-applied device .

Active Comparator: Treatment Group
Composed of one phase of 8 weeks (treatment). The treatment using the self-applied Transcutaneous Electrical Nerve Stimulation (TENS) will prescribe with daily application, twice a day for 20 minutes each application.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy through self-applied device .




Primary Outcome Measures :
  1. Improvement of Pelvic Pain [ Time Frame: up to one year ]
    The chronic pelvic pain will be evaluated by specific instrument (Visual Analogue Scale).

  2. Improvement of Pain during the relation [ Time Frame: up to one year ]
    The deep dyspareunia will be evaluated by specific instrument (Deep Dyspareunia Scale).


Secondary Outcome Measures :
  1. Improvement of Quality of life [ Time Frame: up to one year ]
    The quality of life will be accessed by one specific questionnaire for endometriosis.

  2. Improvement of Sexuality [ Time Frame: up to one year ]
    The sexuality will be accessed by questionnaire.

  3. Improvement of The global pain [ Time Frame: up to one year ]
    The global pain will be evaluated by Diagram Localization and Characterization of Pain (design body representation).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT02769052


Locations
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Brazil
Gynecology Hospital
Campinas, São Paulo, Brazil, 13.083-881
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Ticiana AA Mira, MSc University of Campinas
Study Chair: Cristina L Benetti-Pinto, PhD University of Campinas
Publications:

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Responsible Party: Ticiana Aparecida Alves de Mira, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02769052    
Other Study ID Numbers: 51799115.3.1001.5404
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ticiana Aparecida Alves de Mira, University of Campinas, Brazil:
endometriosis
dyspareunia
physical therapy
sexuality
transcutaneous electrical nerve stimulation
Additional relevant MeSH terms:
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Endometriosis