Status:
NOT_YET_RECRUITING
Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
The intrauterine device (IUD) is a highly effective contraceptive method with increasing utilization in the last decade. The procedure to both place and remove an IUD is typically performed in the amb...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06991075
Start Date
August 1 2025
End Date
November 1 2026
Last Update
May 25 2025
Active Locations (1)
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1
MUSC Women's Health- Cannon Street
Charleston, South Carolina, United States, 29425