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

NCT03187002 | Completed Results FDA Device

• 1 other identifier: IRB-41589
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abortion in First Trimester

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Speculum Placement Pain

  Intraoperative, collected during procedure (up to 30 seconds)

• Tenaculum Placement Pain

  Intraoperative, collected during procedure (up to 30 seconds)

• Paracervical Block Pain

  Intraoperative, collected during procedure (up to 30 seconds)

• Manual Cervical Dilation Pain

  Intraoperative, collected during procedure (up to 30 seconds)

• Speculum Removal Pain

  Intraoperative, collected during procedure (up to 30 seconds)

Study Arms (2)

Transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

Transcutaneous electrical nerve stimulation (TENS)

Device: Transcutaneous electrical nerve stimulation (TENS); Other: SHAM: Moderate IV Sedation

Moderate IV Sedation

ACTIVE COMPARATOR

Fentanyl, versed

Drug: Moderate IV Sedation; Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

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.

Transcutaneous electrical nerve stimulation (TENS)

Moderate IV Sedation DRUG

IV sedation with fentanyl and versed

Moderate IV Sedation

SHAM: Transcutaneous electrical nerve stimulation (TENS) OTHER

Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding

Moderate IV Sedation

SHAM: Moderate IV Sedation OTHER

Sham IV to ensure blinding

Transcutaneous electrical nerve stimulation (TENS)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Planned Parenthood Mar Monte

San Jose, California, 95126, United States

Location

Related Publications (1)

• 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.

  PMID: 34352845 DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Research Manager
• Organization: Stanford University

fpresearch@stanford.edu

6507211567

Study Officials

• Principal Investigator, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: January 18, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Locations

US (1)