|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 January 2021 |
|
Main ID: |
NCT02769052 |
|
Date of registration:
|
06/05/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
TENS Self-applied in the Complementary Treatment of Deep Endometriosis
tici_mira |
|
Scientific 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 |
|
Date of first enrolment:
|
June 2016 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02769052 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Ticiana AA Mira, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Campinas |
|
|
Name:
|
Cristina L Benetti-Pinto, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Campinas |
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Endometriosis
|
|
Intervention(s)
|
|
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
|
|
Primary Outcome(s)
|
|
Improvement of Pelvic Pain
[Time Frame: up to one year]
|
|
Improvement of Pain during the relation
[Time Frame: up to one year]
|
|
Secondary Outcome(s)
|
|
Improvement of The global pain
[Time Frame: up to one year]
|
|
Improvement of Sexuality
[Time Frame: up to one year]
|
|
Improvement of Quality of life
[Time Frame: up to one year]
|
|
Secondary ID(s)
|
|
51799115.3.1001.5404
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|