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Shocking away the pain: TENS device tested for endometriosis flares

NCT ID NCT05348005

Symptom relief Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tested whether a TENS unit, a small device that sends mild electrical pulses through the skin, can reduce pain during endometriosis flares. Forty women with surgically confirmed endometriosis tracked their pain for three months without the device, then for three months while using it during flares. The goal was to see if the TENS unit lowered daily pain scores and improved quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TENS unit (a device that sends mild electrical pulses through the skin to relieve pain)
What this could lead to
If it works, this could offer a drug-free, low-risk option for managing endometriosis flare pain at home.
What could go wrong
This is a small, completed crossover study with only 40 participants. Results may not apply to everyone, and the effect may be modest or no better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Jul 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Females ages 18-45 years at time of enrollment 2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis 3. Average monthly endometriosis pain flare 4. Naïve TENS user Exclusion Criteria: 1. TENS device exclusion: 1. Implantable devices (pacemaker, Interstim, etc.) 2. Cardiac arrhythmia 3. Open skin sores over areas of placement 2. Pregnancy 3. Nursing or trying to conceive at this time 4. Post-operative \<12 weeks from abdominal or pelvic surgery 5. Planned surgery or hormonal medication changes for duration of study if applicable 6. Non-English speaking or inability to read and understand English 7. Prisoners

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Conditions

The condition(s) this trial relates to.

endometriosis Pelvic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis Pelvic pain

Contacts and locations

Locations

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.