TENS for Endometriosis Pain in Adolescents and Young Adults

NCT ID: NCT06914752

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Conditions

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Endometriosis (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Delayed intervention trial. Individuals will be randomized to immediate or delayed treatment with the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate intervention

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

transcutaneous electrical nerve stimulation

Delayed Intervention

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

transcutaneous electrical nerve stimulation

Interventions

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TENS

transcutaneous electrical nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Boskey

Co-Director of Research, Division of Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00050840

Identifier Type: -

Identifier Source: org_study_id

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