Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

Pain Clinical Trial

Official title:

A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245655
• Other study ID #: STUDY-23-01562
• Secondary ID: SFP17-UL4
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Lauren Kus, MD
• Phone: (260) 409-6622
• Email: lauren.kus[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The researchers will recruit eligible participants from patients who opt for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service at Mount Sinai Hospital, Mount Sinai Beth Israel, Mount Sinai Morningside, and Mount Sinai West. Allocation to treatment will be based on a 1:1 blocked randomization scheme stratified by parity. A member of the research/clinical team other than the person performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The team member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete (<5 minutes), the person performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.

REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.

IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.

The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:

1. Baseline

2. Immediately after bimanual exam

3. Immediately after speculum insertion

4. Immediately after tenaculum placement

5. Immediately after uterine sounding

6. Immediately after IUD insertion

7. 5 minutes after speculum removal

The third survey will ask participants about reflections on their experience with IUD insertion and acceptability of the TENS device. Participation in the study is expected to only last one day, the day of IUD insertion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation (TENS)
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.

Locations

Country	Name	City	State
United States	Mount Sinai Beth Israel	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Mount Sinai Morningside	New York	New York
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post Procedure Survey	Factors other than exposure to TENS associated with higher reported pain, Acceptability of the TENS device. Questions answered as yes or no. This is not a scale and has no min or max score.	Day 1 (Day of IUD Insertion)