Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

April 21, 2021 updated by: Planned Parenthood of Greater New York

A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

This is a double-blinded, randomized, placebo-controlled trial evaluating the use of High-frequency Transcutaneous Electrical Nerve Stimulation (HfTENS) compared to sham TENS for pain control during medication abortion with mifepristone and misoprostol through 70 days' gestation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10012
        • Planned Parenthood of New York City - Margaret Sanger Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients seeking medication abortion with a definite, singleton, intrauterine pregnancy (IUP) < 70 days' gestation on ultrasound
  • Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score > 4
  • Age equal to or greater than 18 years
  • Provide informed consent to participate
  • Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone

Exclusion Criteria:

  • Contraindication to medication abortion
  • Allergy to mifepristone or misoprostol
  • Contraindication or allergy to ibuprofen
  • History of cardiac arrhythmia
  • Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker
  • History of chronic pain disorder
  • Any opioid use during previous 30 days
  • Current or prior use of TENS
  • BMI > 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TENS
Device: high frequency TENS treatment
Treatment with high frequency for minimum of 1 hour after misoprostol administration
SHAM_COMPARATOR: Sham TENS
Device: Sham TENS treatment
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on numeric rating scale
Time Frame: 8 hours following misoprostol
Maximum pain score on an 11-point numeric rating scale, where 0 is no pain, and 10 is the worst pain.
8 hours following misoprostol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood of Greater New York

Investigators

  • Principal Investigator: Ariella Goldman, MD, Planned Parenthood of Greater New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 11, 2019

Primary Completion (ACTUAL)

March 6, 2020

Study Completion (ACTUAL)

March 13, 2020

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (ACTUAL)

April 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TENS MAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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