A Cross-Over Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Females ages 18-45 years at time of enrollment

• A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis

• Average monthly endometriosis pain flare

• Naïve TENS user

Locations
United States
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
Contact Information
Primary
Linda Li, MD
lindali@pennstatehealth.psu.edu
7175310003
Time Frame
Start Date: 2022-07-28
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 40
Treatments
No_intervention: No TENS unit use
All subjects will start with 3 months of no TENS use and diary tracking
Active_comparator: TENS unit use
All subjects will then have 3 months of TENS use during episodes of endometriosis pain flare and diary tracking.
Related Therapeutic Areas
Sponsors
Leads: Milton S. Hershey Medical Center

This content was sourced from clinicaltrials.gov