TENS Unit To Decrease Pain After Laminaria Insertion

NCT06529003 | Completed FDA Device

• 1 other identifier: RA-2024-018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn more about the transcutaneous nerve stimulation (TENS) unit, an over-the-counter option for pain relief that is not a medication. The investigators are hoping to find out if this device decreases pain during and after laminaria placement for patients undergoing both elective and medically indicated second-trimester termination of pregnancy.

Conditions

Second Trimester Abortion

Outcome Measures

Primary Outcomes (1)

• Maximum pain scores

  To compare the maximum pain scores reported during the interval between osmotic dilator placement and D\&E procedure of patients receiving the standard of care plus placebo and those who use an adjunctive transcutaneous electrical nerve stimulation (TENS) unit in addition to standard of care. Participants will be asked to rank their pain on an 11-point numerical rating scale (0 to 10), with higher numbers indicating worse pain.

  Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

Secondary Outcomes (6)

• Pain at time of laminaria insertion

  At time of laminaria insertion

• Number of TENS sessions

  Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

• Duration of each TENS sessions

  Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

• Satisfaction with pain management

  Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

• Ease of use

  Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Device: Placebo

TENS unit

ACTIVE COMPARATOR

Device: Transcutaneous Electrical Nerve Stimulation (TENS) unit

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) unit DEVICE

All participants in this study will receive the standard of care, which includes oral ibuprofen and a paracervical block at the time of laminaria insertion. Those in the treatment group will receive an adjunctive TENS unit with specific instructions for use in the interval between laminaria insertion and dilation and evacuation the next day. TENS is a non-invasive, inexpensive, over-the-counter, nonpharmacologic option to relieve pain. All participants will be provided with 15 tabs of ibuprofen 200 mg for outpatient pain control after the procedure. Participants will be instructed to take 600-800 mg of ibuprofen with food every 6 hours as needed for pain during the time period after laminaria insertion and before dilation and evacuation surgery, which is generally less than 24 hours.

TENS unit

Placebo DEVICE

Participants in the placebo group will be given a TENS unit without a battery with similar to the intervention group but will be advised that they may or may not feel a sensation from the electrodes. All participants will be provided with 15 tabs of ibuprofen 200 mg for outpatient pain control after the procedure. Participants will be instructed to take 600-800 mg of ibuprofen with food every 6 hours as needed for pain during the time period after laminaria insertion and before dilation and evacuation surgery, which is generally less than 24 hours.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients undergoing laminaria insertion for D\&E procedure
• Age 18 years or older
• Capability and willingness to send and receive SMS messages by phone and complete web-based surveys
• Capability to read and understand directions for using a TENS unit
• Capability to operate a TENS unit according to provided directions

You may not qualify if:

• Inability to complete the informed consent in English
• Exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the D\&E procedure
• Contraindication to ibuprofen or bupivacaine
• Contraindication to TENS, including cardiac pacemakers, epilepsy, bleeding disorders, cancer, and concurrent use near transdermal drug delivery systems
• Previous participation in this trial
• Prior use of TENS unit

Sponsors & Collaborators

• Queen's Medical Center: lead
• University of Hawaii Foundation: collaborator

Study Sites (1)

1380 Lusitana St. Ste 1004

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Melissa Natavio, MD, MPH

  Complex Family Planning, The Queens Medical Center, Department of Obstetrics, Gynecology, and Womens Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 31, 2024
• Study Start: August 14, 2024
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)