High-frequency nerve stimulation to reduce pain during IUD insertion

A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement

This test checks whether high-frequency transcutaneous electrical nerve stimulation (hfTENS), a handheld non-drug device, reduces pain for adults having an IUD placed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT06991075 on ClinicalTrials.gov

What this trial studies

This interventional study applies high-frequency transcutaneous electrical nerve stimulation (hfTENS) during ambulatory IUD insertion to measure its effect on insertion pain. Eligible English-speaking adults (age 18+) presenting for initial placement of a levonorgestrel 52 mg or copper T380A IUD at MUSC will receive the hfTENS intervention and pain will be recorded using standard visual analog scales. Participants with contraindications such as pregnancy, active pelvic infection, implantable cardiac devices, recent opioid use, chronic pain disorders, prior TENS use, or BMI >50 are excluded. The device delivers >50 Hz topical electrical stimulation intended to alter pain signaling and has shown benefit in dysmenorrhea and other outpatient gynecologic procedures.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults (18+) presenting to MUSC Women's Health for initial insertion of a levonorgestrel 52 mg or copper T380A IUD without contraindications.

Not a fit: People with cardiac arrhythmias or implantable electrical devices, recent opioid use, chronic pain disorders, BMI >50, active pelvic infection or pregnancy, or prior TENS use are excluded and therefore unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, hfTENS could provide a low-cost, nonpharmacologic way to reduce discomfort during IUD placement and improve the patient experience.

How similar studies have performed: Prior studies report that high-frequency TENS reduces pain in dysmenorrhea and several outpatient gynecologic procedures, indicating promising prior evidence for this approach.

Eligibility criteria

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

Where this trial is running

Charleston, South Carolina

• MUSC Women's Health- Cannon Street — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Jesslyn Payne

Conditions Pain; Obstetrics and Gynecology