Recruiting

hfTENS

Sponsor:

Medical University of South Carolina

Code:

NCT06991075

Conditions

Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High frequency transcutaneous electrical nerve stimulation

Study Details

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.

Conditions

Pain

Study ID

NCT06991075

Start date

Dec 1, 2025

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

High frequency transcutaneous electrical nerve stimulation

TENS 7000 digital TENS unit will be used.

Primary outcome measure

  • Pain scores reported at IUD insertion [ Time Frame: From enrollment until 5 minutes after procedure completion ]

Central Contacts and Locations

Central contacts

Jesslyn Payne

(843)-792-7525paynej@musc.edu

Michelle Meglin, MD

843-792-4026meglin@musc.edu

Locations

MUSC Women's Health- Cannon Street

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Angela Dempsey, MD

843-792-5300

More Information

Sponsor

Medical University of South Carolina

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • Obstetrics and Gynecology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-02-09.