N/A
N=153
Acupuncture for Pain Management During Uterine Aspiration
Pain Acute · Acupuncture
Bottom Line
View on ClinicalTrials.gov: NCT03391986 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care — 39.5; 71.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SEIRIN® Pyonex™ Acupuncture Needles (Device); 12 mm Plasters (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care |
39.5; 71.0 | — |
| SECONDARY Change in Visual Analog Scale for Pain (VAS Pain) Score - Placebo Versus Routine Care |
70.0; 71.0 | — |
| SECONDARY Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care |
94; 76 | — |
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.
Eligibility Criteria
Inclusion Criteria
- English- or Spanish-speaking women
- Age 18 or older
- Seeking first trimester suction aspiration for undesired pregnancy, early pregnancy failure, retained products of conception, or molar pregnancy
- Intrauterine pregnancy with gestational age less than or equal to 12 weeks and 6 days
- Willingness to receive acupuncture and be randomized in the study
Exclusion Criteria
- Allergy to adhesives
- Allergy to or cannot receive ibuprofen or 1% lidocaine
- Congenital anomalies of the ear including anotia and microtia
Data sourced from ClinicalTrials.gov (NCT03391986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.