BridgeMD
New treatment option for Pain
Official title Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
ClinicalTrials.gov ID: NCT06991075
What this study is testing
- What it's testing
- Investigators are conducting a study to determine whether high frequency transcutaneous electrical nerve stimulation (hfTENS) is effective at reducing pain in women having an IUD inserted.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.