TENS for Endometriosis Pain in Adolescents and Young Adults

Not Applicable

Not yet recruiting

• Conditions: Endometriosis (Diagnosis)

• Registration Number: NCT06914752
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-06
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain - Visual Acuity Scale	6 months	Pain on a scale of 0-10, where a higher score indicates worse pain.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States