Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement

NCT06991075 | Recruiting DMC FDA Device

• 1 other identifier: Pro00143776
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

Obstetrics and Gynecology

Outcome Measures

Primary Outcomes (1)

• Pain scores reported at IUD insertion

  Pain scores at time of IUD insertion as measured by VAS scores between TENS and placebo groups

  From enrollment until 5 minutes after procedure completion

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

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.

Device: High frequency transcutaneous electrical nerve stimulation

Placebo TENS

PLACEBO COMPARATOR

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.

Device: High frequency transcutaneous electrical nerve stimulation

Interventions

High frequency transcutaneous electrical nerve stimulation DEVICE

TENS 7000 digital TENS unit will be used.

Active TENS; Placebo TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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)
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

MUSC Women's Health- Cannon Street

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jesslyn Payne

CONTACT

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

Michelle Meglin, MD

CONTACT

843-792-4026; meglin@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)