NCT03187002

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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
OTHER	SHAM: Moderate IV Sedation	Sham IV to ensure blinding

Timeline

• Start date: 2018-01-18
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2017-06-14
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study