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TENS for Endometriosis Pain

N/A
Recruiting
Led By Kristin W Riley, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
Females ages 18-45 years at time of enrollment
Must not have
Post-operative <12 weeks from abdominal or pelvic surgery
TENS device exclusion: Cardiac arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline period (months 1-3) and treatment period (months 4-6)
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers see if TENS units help decrease endometriosis flare pain.

Who is the study for?
This trial is for women aged 18-45 who have been diagnosed with endometriosis through surgery or tissue examination, experience monthly pain flares from it, and have never used a TENS unit. It's not for those with pacemakers, heart rhythm problems, open skin sores where the device goes, or if pregnant/nursing/trying to conceive. Participants must speak and understand English.
What is being tested?
The study tests whether a TENS (Transcutaneous Electrical Nerve Stimulation) unit can reduce pain during endometriosis flare-ups. For three months participants will track their pain without the device; then they'll use the TENS unit for another three months while recording their symptoms.
What are the potential side effects?
While using a TENS unit is generally safe, potential side effects may include skin irritation at the site of electrode placement and discomfort or muscle twitching during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My endometriosis was confirmed through surgery or biopsy.
Select...
I am a woman aged between 18 and 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had surgery in my abdomen or pelvis less than 12 weeks ago.
Select...
I do not have an irregular heartbeat.
Select...
I do not have open skin sores where a TENS device would be placed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline period (months 1-3) and treatment period (months 4-6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline period (months 1-3) and treatment period (months 4-6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Average Daily VAS Pain Score
Secondary study objectives
Change in Female Sexual Function Index Total Score using the FSFI questionnaire
Change in Quality of Life Score from baseline to end of study using the EHP30 questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: No TENS unit useActive Control1 Intervention
All subjects will start with 3 months of no TENS use and diary tracking
Group II: TENS unit useActive Control1 Intervention
All subjects will then have 3 months of TENS use during episodes of endometriosis pain flare and diary tracking.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
510 Previous Clinical Trials
2,796,434 Total Patients Enrolled
7 Trials studying Endometriosis
566 Patients Enrolled for Endometriosis
Kristin W Riley, MDPrincipal InvestigatorPenn State Health Hershey Medical Center

Media Library

TENS unit use Clinical Trial Eligibility Overview. Trial Name: NCT05348005 — N/A
Endometriosis Research Study Groups: No TENS unit use, TENS unit use
Endometriosis Clinical Trial 2023: TENS unit use Highlights & Side Effects. Trial Name: NCT05348005 — N/A
TENS unit use 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348005 — N/A
~8 spots leftby Jun 2025
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