NCT06991075

Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	High frequency transcutaneous electrical nerve stimulation	TENS 7000 digital TENS unit will be used.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-05-25
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study