A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
South Carolina
MUSC Women's Health- Cannon Street
RECRUITING
Charleston
Contact Information
Primary
Jesslyn Payne
paynej@musc.edu
(843)-792-7525
Backup
Michelle Meglin, MD
meglin@musc.edu
843-792-4026
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 86
Treatments
Active_comparator: Active TENS
A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. For the active treatment group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Placebo_comparator: Placebo TENS
A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. The TENS device will not be turned on.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: Icahn School of Medicine at Mount Sinai