Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

NCT06245655 | Completed FDA Device

• 2 other identifiers: STUDY-23-01562SFP17-UL4
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Visual Analog Scale

  Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain

  Day 1 (Day of IUD Insertion)

Secondary Outcomes (1)

• Post Procedure Survey

  Day 1 (Day of IUD Insertion)

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

For the Active TENS 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: Transcutaneous Electrical Nerve Stimulation (TENS)

Placebo TENS

PLACEBO COMPARATOR

For the placebo TENS group, setup will be identical, but the device will not be turned on.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. 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.

Active TENS; Placebo TENS

Eligibility Criteria

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

You may qualify if:

• In order to participate in the study, an individual must meet all the following criteria:
• Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service
• Provision of signed and dated informed consent form for IUD Insertion
• English speaking and age 18 or older
• Opting for either LNG 52mg or copper T380A IUD
• Stated willingness to comply with all study procedures

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) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl)
• History of epilepsy

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (5)

Center for Women's Health and Midwifery

New Haven, Connecticut, 06519, United States

Location

Yale Family Planning Clinic

New Haven, Connecticut, 06519, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Mount Sinai Union Square

New York, New York, 10003, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Lauren Kus, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

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: Complex Family Planning Fellow

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: March 25, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)