Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During Cervical Dilator Placement Prior to Dilation and Evacuation

NCT03868787 | Completed Results FDA Device

• 1 other identifier: STU00209157
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the use of Transcutaneous Electrical Nerve Stimulation (TENS) as a method of pain control during osmotic dilator insertion prior to dilation and evacuation. Half the group will have an active TENS unit and half will have a sham or placebo TENS unit.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Following Dilator Placement

  Self-reported pain on 100mm visual analog scale (VAS) immediately following dilator placement. Range is from 0mm to 100mm, with 0mm being the least amount of pain (minimum score) and 100mm being the greatest (maximum score). Higher values are considered a worse outcome.

  within 5 mins after dilator placement procedure

Secondary Outcomes (2)

• Interval Pain

  5 mins after dilator placement to 36 hours after dilator placement

• Patient Satisfaction

  24-36 hours after dilator placement, immediately prior to D&E

Study Arms (2)

Active TENS

EXPERIMENTAL

The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation

Device: TENS

Sham TENS

SHAM COMPARATOR

The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes

Device: Sham TENS

Interventions

TENS DEVICE

TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.

Active TENS

Sham TENS DEVICE

Non-active TENS unit

Sham TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years of age
• Gestational age between 14 weeks and 23 weeks 6 days
• Willing and able to sign an informed consent in English
• No contraindications to TENS

You may not qualify if:

• Incarceration
• Preterm Premature Rupture of Membranes or evidence of intra-amniotic infection
• Presence of implanted cardiac device
• Lack of sensation to touch on area of electrode placement
• Prior TENS use
• Opioid dependence

Sponsors & Collaborators

• Ashley Turner, MD: lead
• Society of Family Planning: collaborator

Study Sites (1)

Northwestern Center for Family Planning and Contraception

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

• Binder P, Gustafsson A, Uvnas-Moberg K, Nissen E. Hi-TENS combined with PCA-morphine as post caesarean pain relief. Midwifery. 2011 Aug;27(4):547-52. doi: 10.1016/j.midw.2010.05.002. Epub 2010 Jul 7.

  PMID: 20615594 BACKGROUND

• De Angelis C, Perrone G, Santoro G, Nofroni I, Zichella L. Suppression of pelvic pain during hysteroscopy with a transcutaneous electrical nerve stimulation device. Fertil Steril. 2003 Jun;79(6):1422-7. doi: 10.1016/s0015-0282(03)00363-7.

  PMID: 12798892 BACKGROUND

• ELECTROPHYSICAL AGENTS - Contraindications And Precautions: An Evidence-Based Approach To Clinical Decision Making In Physical Therapy. Physiother Can. 2010 Fall;62(5):1-80. doi: 10.3138/ptc.62.5. Epub 2011 Jan 5. No abstract available.

  PMID: 21886384 BACKGROUND

• Olsen MF, Elden H, Janson ED, Lilja H, Stener-Victorin E. A comparison of high- versus low-intensity, high-frequency transcutaneous electric nerve stimulation for painful postpartum uterine contractions. Acta Obstet Gynecol Scand. 2007;86(3):310-4. doi: 10.1080/00016340601040928.

  PMID: 17364305 BACKGROUND

• Johnson MI, Paley CA, Howe TE, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2015 Jun 15;2015(6):CD006142. doi: 10.1002/14651858.CD006142.pub3.

  PMID: 26075732 BACKGROUND

• Kayman-Kose S, Arioz DT, Toktas H, Koken G, Kanat-Pektas M, Kose M, Yilmazer M. Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal delivery and cesarean section. J Matern Fetal Neonatal Med. 2014 Oct;27(15):1572-5. doi: 10.3109/14767058.2013.870549. Epub 2014 Jan 8.

  PMID: 24283391 BACKGROUND

• Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.

  PMID: 25139724 BACKGROUND

• Platon B, Andrell P, Raner C, Rudolph M, Dvoretsky A, Mannheimer C. High-frequency, high-intensity transcutaneous electrical nerve stimulation as treatment of pain after surgical abortion. Pain. 2010 Jan;148(1):114-119. doi: 10.1016/j.pain.2009.10.023. Epub 2009 Dec 2.

  PMID: 19959293 BACKGROUND

• Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.

  PMID: 11869624 BACKGROUND

• Soon R, Tschann M, Salcedo J, Stevens K, Ahn HJ, Kaneshiro B. Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149.

  PMID: 28697113 BACKGROUND

• de Sousa L, Gomes-Sponholz FA, Nakano AM. Transcutaneous electrical nerve stimulation for the relief of post-partum uterine contraction pain during breast-feeding: a randomized clinical trial. J Obstet Gynaecol Res. 2014 May;40(5):1317-23. doi: 10.1111/jog.12345. Epub 2014 Apr 21.

  PMID: 24750301 BACKGROUND

• Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.

  PMID: 24953072 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Small study Population mostly white, non-hispanic Mostly terminating for fetal anomaly, which does not make up the vast majority of terminations

Results Point of Contact

• Title: Ashley Turner, MD Assistant Professor of Obstetrics and Gynecology
• Organization: Northwestern University Feinberg School of Medicine

ashley.turner1@nm.org

2316200549

Study Officials

• Leanne McCloskey, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The experimental group will have an active TENS unit - Chattanooga Primera - and the control group will have a sham TENS unit. The sham TENS will be the same unit without the true TENS electrical connections. The true TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: May 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: April 1, 2021
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)