Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion

NCT05320432 | Completed Results FDA Device

• 1 other identifier: 62478
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

First-trimester abortion aspiration procedures are painful and sedation is typically provided. It is unsafe to drive after sedation due to the prolonged motor delay from some anesthetic agents. Without a known escort, most clinics do not allow patients to use public transportation, taxis, or rideshare services. Arranging a ride may be harder for those seeking abortion care than other surgical procedures given privacy concerns and the need to travel far distances. Additionally, some people have medical reasons that makes sedation in an outpatient abortion clinic unsafe. As abortion restrictions increase and more people need to travel far distances to access care, it is important to investigate non-pharmacologic pain control options. Transcutaneous electrical nerve stimulation (TENS) delivers a low-level electrical current through the skin. By activating the descending inhibitory systems in the central nervous system, these pulses of electrical current reduce sensitivity to pain. TENS has been shown to be effective in decreasing pain with menstrual cramps and during medication abortion, and it was found to be non-inferior to IV sedation for first-trimester procedural abortion. However, it remains unclear if TENS is better than ibuprofen and local anesthesia via paracervical block alone. The overarching goal of this research is to identify an inexpensive, non-pharmacologic, alternative pain control strategy for those with a medical or social contraindication to IV sedation. The specific aim of this project is to evaluate the efficacy of TENS to prevent pain during first-trimester procedural abortion. To achieve this objective, a blinded, randomized superiority trial comparing the use of TENS to sham for management of pain during first-trimester aspiration abortion is proposed. This research is significant because the validation of a non-pharmacologic pain management technique would decrease barriers to accessing abortion care.

Conditions

Abortion in First Trimester; Pain

Outcome Measures

Primary Outcomes (1)

• Pain During Cervical Dilation

  Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")

  Intra-operative, collected during procedure (up to 30 seconds)

Secondary Outcomes (6)

• Pain During Procedure

  Intra-operative, collected during procedure (up to 30 seconds)

• Overall Experience

  Post-operative, collected following procedure (up to 20 minutes)

• Procedure Time

  up to 20 minutes

• Provider Perceived Ease of Procedure

  Post-operative, collected after procedure (up to 30 seconds)

• Time Spent in Recovery

  up to 1 hour

Study Arms (2)

Transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level).

Device: Transcutaneous electrical nerve stimulation (TENS)

Sham

SHAM COMPARATOR

For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation.

Device: Sham

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

A low-level electrical current through the skin activates the descending inhibitory systems in the central nervous system.

Transcutaneous electrical nerve stimulation (TENS)

Sham DEVICE

No current applied through pads.

Sham

Eligibility Criteria

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

You may qualify if:

• years old or older
• English- or Spanish-fluency
• \<12 weeks gestation
• Presenting for aspiration abortion

You may not qualify if:

• Planned use of oral or IV sedation
• Contraindications to office-based procedure as determined by attending physician
• Fetal demise
• Requiring pre-procedure use of misoprostol
• Contraindication to TENS units use (pacemaker or epilepsy)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, 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

Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

gynresearch@stanford.edu

650-497-5175

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: January 20, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)