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Trial Outcomes & Findings for Acupuncture for Pain Management During Uterine Aspiration (NCT NCT03391986)

NCT ID: NCT03391986

Last Updated: 2019-09-03

Results Overview

Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

at the completion of the procedure (approximately 10 minutes later)

Results posted on

2019-09-03

Participant Flow

Participant milestones

Participant milestones
Measure
Pyonex Needles
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. SEIRIN® Pyonex™ Acupuncture Needles: 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
Placebo Adhesives
This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters. 12 mm Plasters: 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
Routine Care
This arm will receive no intervention.
Overall Study
STARTED
53
50
50
Overall Study
COMPLETED
53
50
50
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acupuncture for Pain Management During Uterine Aspiration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pyonex Needles
n=53 Participants
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. SEIRIN® Pyonex™ Acupuncture Needles: 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
Placebo Adhesives
n=50 Participants
This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters. 12 mm Plasters: 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
Routine Care
n=50 Participants
This arm will receive no intervention.
Total
n=153 Participants
Total of all reporting groups
Age, Customized
Age
31 years
STANDARD_DEVIATION 6.8 • n=5 Participants
28.7 years
STANDARD_DEVIATION 6.9 • n=7 Participants
30.9 years
STANDARD_DEVIATION 7.6 • n=5 Participants
30.2 years
STANDARD_DEVIATION 7.06 • n=4 Participants
Sex: Female, Male
Female
53 Participants
n=5 Participants
50 Participants
n=7 Participants
50 Participants
n=5 Participants
153 Participants
n=4 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
43 Participants
n=5 Participants
39 Participants
n=7 Participants
39 Participants
n=5 Participants
121 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=5 Participants
9 Participants
n=7 Participants
9 Participants
n=5 Participants
25 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
7 Participants
n=4 Participants
Region of Enrollment
United States
53 participants
n=5 Participants
50 participants
n=7 Participants
50 participants
n=5 Participants
153 participants
n=4 Participants
Pregnancy type
Induced abortion
39 Participants
n=5 Participants
34 Participants
n=7 Participants
33 Participants
n=5 Participants
106 Participants
n=4 Participants
Pregnancy type
Spontaneous abortion
14 Participants
n=5 Participants
16 Participants
n=7 Participants
17 Participants
n=5 Participants
47 Participants
n=4 Participants

PRIMARY outcome

Timeframe: at the completion of the procedure (approximately 10 minutes later)

Population: The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group.

Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales.

Outcome measures

Outcome measures
Measure
Pyonex Needles
n=52 Participants
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. SEIRIN® Pyonex™ Acupuncture Needles: 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
Routine Care
n=49 Participants
This arm will receive no intervention.
Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care
39.5 score on a scale
Interval 11.0 to 63.0
71.0 score on a scale
Interval 33.0 to 90.0

SECONDARY outcome

Timeframe: prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later)

Population: The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group.

Measure effectiveness of placebo as an adjunct to ibuprofen and paracervical block for pain control during uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive placebo adhesives and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life).

Outcome measures

Outcome measures
Measure
Pyonex Needles
n=49 Participants
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. SEIRIN® Pyonex™ Acupuncture Needles: 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
Routine Care
n=49 Participants
This arm will receive no intervention.
Change in Visual Analog Scale for Pain (VAS Pain) Score - Placebo Versus Routine Care
70.0 score on a scale
Interval 1.0 to 81.0
71.0 score on a scale
Interval 33.0 to 90.0

SECONDARY outcome

Timeframe: at the completion of the procedure (approximately 5-10 minutes)

Population: The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group.

Using a satisfaction survey (investigator-developed, 6 questions, each question is graded on a scale of 1-5, 1 being very poor and 5 being very good) to measure effectiveness of auricular acupuncture for improving satisfaction.

Outcome measures

Outcome measures
Measure
Pyonex Needles
n=52 Participants
This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles. SEIRIN® Pyonex™ Acupuncture Needles: 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
Routine Care
n=49 Participants
This arm will receive no intervention.
Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care
94 percentage of participants
76 percentage of participants

Adverse Events

Pyonex Needles

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Adhesives

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Routine Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Westhoff, MD

Columbia University

Phone: 212-305-4805

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place