TENS for Endometriosis Pain in Adolescents and Young Adults

Boston Children's Hospital

Status: Begins enrollment in 3 months

Conditions: Endometriosis (Diagnosis)

Treatments: Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06914752

IRB-P00050840

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Immediate intervention

Experimental group

Treatment:

Device: TENS

Delayed Intervention

Experimental group

Treatment:

Device: TENS