CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
SEIRIN® Pyonex™ Acupuncture Needles +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03391986
NCT03391986N/ACompleted

Auricular Acupuncture as Adjunct for Pain Management During First Trimester Uterine Aspiration.

Columbia University·interventional·Posted Jan 5, 2018·Updated Sep 3, 2019

In Brief

A clinical study evaluating SEIRIN® Pyonex™ Acupuncture Needles and 12 mm Plasters for Pain Acute and Acupuncture. Completed, enrolled 153 participants across 1 site.

Detailed Summary

The proposed study will be a randomized, double blinded, placebo-controlled trial to evaluate the efficacy of auricular acupuncture as adjunct for pain management during abortion. Women seeking first trimester uterine aspiration procedure who enroll in the study will be randomized to receive: 1) auricular acupuncture using pyonex needles, 2) placebo using an adhesive, 3) or routine care. Both participants and the treating physician will be unaware of treatment assignment. The primary outcome will compare the maximum pain score as measured by the visual analog scale (VAS) between the auricular acupuncture group and the routine care group. The secondary outcome will compare the maximum pain score between placebo group to the routine care group. The study will also investigate patient satisfaction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 5, 2018
Enrollment StartSep 9, 2017
Primary CompletionApr 30, 2018
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.5 years ago

Interventions

SEIRIN® Pyonex™ Acupuncture Needlesdevice

Needles will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix

12 mm Plastersprocedure

12 mm (0.5"). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix