Shock therapy for IUD pain? new trial tests TENS device
NCT ID NCT06991075
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tests whether a high-frequency TENS device can reduce pain when an IUD is placed. About 86 women will be randomly assigned to receive either TENS or a placebo device during the procedure. Researchers will measure pain scores right at insertion to see if TENS helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous electrical nerve stimulation (TENS) device
- What this could lead to
- If it works, this could offer a simple, drug-free way to ease pain during IUD insertion.
- What could go wrong
- This is a small, early-phase trial. The effect may be small or no better than placebo, and results may not apply to all women.
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
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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
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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: * Provision of signed and dated informed consent form for IUD Insertion * Stated willingness to comply with all study procedures * English speaking individuals aged 18 years or older * Presenting for IUD initiation during ambulatory care visit at MUSC Women's Health * Opting for either LNG 52mg or copper T380A IUD Exclusion Criteria: * Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy) * Contraindication or allergy to ibuprofen * History of a chronic pain disorder * Recent opioid use in the previous 30 days * History of a cardiac arrhythmia * History of heart disease (i.e. atrial fibrillation, congestive heart failure) * Presence of an implantable device with an electrical discharge (i.e. pacemaker) * BMI \> 50 (class IV obesity) * History of TENS use * Planned pain intervention outside standard of care (i.e. paracervical block, misoprotol) OR preprocedure use of non-standard pain medication (i.e. benzodiazepines, marijuana, muscle relaxers, gabapentin, benadryl) * History of epilepsy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MUSC Women's Health- Cannon Street
RECRUITINGCharleston, South Carolina, 29425, United States
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