TENS for Endometriosis Pain in Adolescents and Young Adults

NCT06914752 | Withdrawn FDA Device

• 1 other identifier: IRB-P00050840
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis (Diagnosis)

Keywords

endometriosis; TENS; transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Pain - Visual Acuity Scale

  Pain on a scale of 0-10, where a higher score indicates worse pain.

  6 months

Secondary Outcomes (2)

• Endometriosis Health Profile 30 (EHP-30)

  6 months

• Missed school/work

  6 months

Study Arms (2)

Immediate intervention

EXPERIMENTAL

Device: TENS

Delayed Intervention

EXPERIMENTAL

Device: TENS

Interventions

TENS DEVICE

transcutaneous electrical nerve stimulation

Delayed Intervention; Immediate intervention

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Endometriosis; Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Research, Division of Gynecology

Model Details: Delayed intervention trial. Individuals will be randomized to immediate or delayed treatment with the intervention.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)