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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up/Treatment - Control Group | Active Comparator | 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. |
|
| Treatment Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Device | Electrotherapy through self-applied device . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Pelvic Pain | The chronic pelvic pain will be evaluated by specific instrument (Visual Analogue Scale). | up to one year |
| Improvement of Pain during the relation | The deep dyspareunia will be evaluated by specific instrument (Deep Dyspareunia Scale). | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Quality of life | The quality of life will be accessed by one specific questionnaire for endometriosis. | up to one year |
| Improvement of Sexuality | The sexuality will be accessed by questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ticiana AA Mira, MSc | University of Campinas | Principal Investigator |
| Cristina L Benetti-Pinto, PhD | University of Campinas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecology Hospital | Campinas | São Paulo | 13.083-881 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6769717 | Background | Dizerega GS, Barber DL, Hodgen GD. Endometriosis: role of ovarian steroids in initiation, maintenance, and suppression. Fertil Steril. 1980 Jun;33(6):649-53. doi: 10.1016/s0015-0282(16)44780-1. | |
| 15980014 | Background | 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. doi: 10.1093/humrep/dei135. Epub 2005 Jun 24. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004414 | Dyspareunia |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| up to one year |
| 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 |
| 15749483 | Background | 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. doi: 10.1016/j.fertnstert.2004.07.973. |
| 11108885 | Background | 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. doi: 10.1016/s0039-128x(00)00190-2. |
| 9764869 | Background | 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. doi: 10.1016/0020-7292(95)02359-k. |
| 5320816 | Background | Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available. |
| 1026900 | Background | Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available. |
| 11506842 | Background | 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. doi: 10.1016/s0029-7844(01)01433-8. |
| 19142521 | Background | 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. doi: 10.1590/s0100-72032008000800003. Portuguese. |
| 22358342 | Background | Minson FP, Abrao MS, Sarda Junior 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. |
| 10782451 | Background | 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. doi: 10.1080/009262300278597. |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |