Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial

High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.

Study Overview

• Status: Completed
• Conditions: Abortion in First Trimester
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation (TENS); Other: SHAM: Moderate IV Sedation; Drug: Moderate IV Sedation; Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95126
      • Planned Parenthood Mar Monte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Presenting for surgical abortion
• Gestational age <12 weeks
• < 18 years of age
• Agrees to be randomized

Exclusion criteria:

• Allergy to study medications (lidocaine, fentanyl, midazolam)
• > 18 years of age
• Fetal demise
• Pre-procedure use of misoprostol
• No means of transportation following procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transcutaneous electrical nerve stimulation (TENS)	Device: Transcutaneous electrical nerve stimulation (TENS); Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.; Other: SHAM: Moderate IV Sedation; Sham IV to ensure blinding
ACTIVE_COMPARATOR: Moderate IV Sedation; Fentanyl, versed	Drug: Moderate IV Sedation; IV sedation with fentanyl and versed; Other: SHAM: Transcutaneous electrical nerve stimulation (TENS); Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspiration Pain	Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speculum Placement Pain	Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Tenaculum Placement Pain	Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Paracervical Block Pain	Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Manual Cervical Dilation Pain	Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Speculum Removal Pain	Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")	Intraoperative, collected during procedure (up to 30 seconds)
Total Procedure Time	Time from speculum placement to speculum removal, measured in minutes	Intraoperative, collected during procedure (up to 20 minutes)

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB-41589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes