TENS Self-applied in the Complementary Treatment of Deep Endometriosis

NCT02769052 | Completed

• 1 other identifier: 51799115.3.1001.5404
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

endometriosis; dyspareunia; physical therapy; sexuality; transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Improvement of Quality of life

  up to one year

• Improvement of Sexuality

  up to one year

• Improvement of The global pain

  up to one year

Study Arms (2)

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Electrotherapy through self-applied device .

Follow-up/Treatment - Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women at reproductive age;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Gynecology Hospital

Campinas, São Paulo, 13.083-881, Brazil

Location

Related Publications (11)

• 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.

  PMID: 6769717 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.

  PMID: 15980014 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.

  PMID: 15749483 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.

  PMID: 11108885 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.

  PMID: 9764869 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.

  PMID: 5320816 BACKGROUND

• Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.

  PMID: 1026900 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.

  PMID: 11506842 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.

  PMID: 19142521 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.

  PMID: 22358342 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.

  PMID: 10782451 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Dyspareunia; Sexuality

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ticiana AA Mira, MSc

  University of Campinas

  PRINCIPAL INVESTIGATOR

• Cristina L Benetti-Pinto, PhD

  University of Campinas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)