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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline period (months 1-3) and treatment period (months 4-6)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My endometriosis was confirmed through surgery or biopsy.
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I am a woman aged between 18 and 45.
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My endometriosis was confirmed through surgery or biopsy.
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I experience frequent endometriosis pain flares monthly.
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I am a woman aged between 18 and 45.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Average Daily VAS Pain Score
Secondary outcome measures
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

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
491 Previous Clinical Trials
2,798,765 Total Patients Enrolled
6 Trials studying Endometriosis
536 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to join this study?

"The trial, which was initially posted on July 28th 2022 and updated as recently as the same date is currently recruiting patients according to clinicaltrials.gov."

Answered by AI

Who is eligible to partake in the experiment?

"This clinical trial seeks 40 individuals suffering from pelvic pain and aged between 18-45 years old. To be eligible, they must exhibit monthly endometriosis flare ups, have no prior experience with TENS therapy, and a confirmation of the condition either through surgery or histopathology."

Answered by AI

Is this research endeavor accepting participants aged 85 or above?

"As per the prerequisites for this clinical trial, eligible candidates must be between 18 and 45 years of age."

Answered by AI

How many participants have been selected for this clinical trial?

"Affirmative. The clinicaltrials.gov database shows that this research is currently recruiting participants; the project was initially posted on July 28th 2022 and last amended on the same date. Forty patients must be recruited from one site for this trial to proceed as planned."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Penn State Health Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have not tried any thing for my.
PatientReceived 2+ prior treatments
Recent research and studies
~8 spots leftby Sep 2024