Endometriosis (Diagnosis)
Conditions
Keywords
endometriosis, TENS, transcutaneous electrical nerve stimulation
Brief summary
The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.
Interventions
DEVICETENS
transcutaneous electrical nerve stimulation
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Delayed intervention trial. Individuals will be randomized to immediate or delayed treatment with the intervention.
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent girls and young women (13-25) * Diagnosis of endometriosis, * Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment. * Personal smart phone or mobile device * Speak either English or Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain - Visual Acuity Scale | 6 months | Pain on a scale of 0-10, where a higher score indicates worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometriosis Health Profile 30 (EHP-30) | 6 months | The Endometriosis Health Profile is a 30 item patient-reported outcome measures designed to assess the health-related quality of life of people living with endometriosis. Scores range from 0 to 100 with higher scores being associated with WORSE health related quality of life. |
| Missed school/work | 6 months | Individuals will be asked to track the number of days of missed school/work. |
Countries
United States
Outcome results
None listed