TENS Self-applied in the Complementary Treatment of Deep Endometriosis

Endometriosis Clinical Trial

— tici_mira  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769052
• Other study ID #: 51799115.3.1001.5404
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 2019

Study information

• Verified date: December 2020
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy through self-applied device .

Locations

Country	Name	City	State
Brazil	Gynecology Hospital	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

Carpenter SE, Tjaden B, Rock JA, Kimball A. The effect of regular exercise on women receiving danazol for treatment of endometriosis. Int J Gynaecol Obstet. 1995 Jun;49(3):299-304. — View Citation

Chwalisz K, Brenner RM, Fuhrmann UU, Hess-Stumpp H, Elger W. Antiproliferative effects of progesterone antagonists and progesterone receptor modulators on the endometrium. Steroids. 2000 Oct-Nov;65(10-11):741-51. Review. — View Citation

Dizerega GS, Barber DL, Hodgen GD. Endometriosis: role of ovarian steroids in initiation, maintenance, and suppression. Fertil Steril. 1980 Jun;33(6):649-53. — View Citation

Ferrero S, Esposito F, Abbamonte LH, Anserini P, Remorgida V, Ragni N. Quality of sex life in women with endometriosis and deep dyspareunia. Fertil Steril. 2005 Mar;83(3):573-9. — View Citation

Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001 Aug;98(2):258-64. — View Citation

Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. Epub 2005 Jun 24. — View Citation

Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review. — View Citation

Mengarda CV, Passos EP, Picon P, Costa AF, Picon PD. [Validation of Brazilian Portuguese version of quality of life questionnaire for women with endometriosis (Endometriosis Health Profile Questionnaire--EHP-30)]. Rev Bras Ginecol Obstet. 2008 Aug;30(8):384-92. Portuguese. — View Citation

Minson FP, Abrão MS, Sardá Júnior J, Kraychete DC, Podgaec S, Assis FD. [Importance of quality of life assessment in patients with endometriosis]. Rev Bras Ginecol Obstet. 2012 Jan;34(1):11-5. Portuguese. — View Citation

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. — View Citation

Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Pelvic Pain	The chronic pelvic pain will be evaluated by specific instrument (Visual Analogue Scale).	up to one year
Primary	Improvement of Pain during the relation	The deep dyspareunia will be evaluated by specific instrument (Deep Dyspareunia Scale).	up to one year
Secondary	Improvement of Quality of life	The quality of life will be accessed by one specific questionnaire for endometriosis.	up to one year
Secondary	Improvement of Sexuality	The sexuality will be accessed by questionnaire.	up to one year
Secondary	Improvement of The global pain	The global pain will be evaluated by Diagram Localization and Characterization of Pain (design body representation).	up to one year