Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement

NCT ID: NCT06991075

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-11-30

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 ambulatory gynecologic clinic. Pain associated with IUD insertion is variably described, and evidence suggests that physicians underestimate the severity of pain patients experience with this procedure. Studies have quantified the experience of pain using visual analog scales, demonstrating moderate insertional pain ranging from 5 to 7 out of 10 cm (equivalent to 50-70 out of 100 mm) on VAS. Increasingly, both academic and lay media reports highlight that traumatic nature of a painful IUD placement and call providers to acknowledge and address the pain of IUD placement in a meaningful way.

To date, research has not identified a highly effective strategy to reduce pain during IUD placement. Transcutaneous electrical nerve stimulation (TENS) is a low-cost, low-risk, nonpharmacologic intervention for pain management. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction. High frequency TENS (>50 Hz; "hfTENS") significantly reduces pain associated with dysmenorrhea and a range of outpatient gynecologic procedures, including medication abortion, hysteroscopy, and uterine aspiration. This study evaluates an intervention to address pain during IUD placement in the ambulatory setting.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High frequency transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

TENS 7000 digital TENS unit will be used.

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.

Group Type: PLACEBO_COMPARATOR

High frequency transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

TENS 7000 digital TENS unit will be used.

Interventions

High frequency transcutaneous electrical nerve stimulation

TENS 7000 digital TENS unit will be used.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Michelle Meglin

meglin@musc.edu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MUSC Women's Health- Cannon Street

Charleston, South Carolina, United States

Countries

United States

Central Contacts

Jesslyn Payne

Role: CONTACT

paynej@musc.edu

(843)-792-7525

Michelle Meglin, MD

Role: CONTACT

meglin@musc.edu

843-792-4026

Facility Contacts

Angela Dempsey, MD

Role: primary

843-792-5300

Other Identifiers

Pro00143776

Identifier Type: -

Identifier Source: org_study_id