Trial Outcomes & Findings for Battlefield Auricular Acupuncture for Control of Post-partum Pain (NCT NCT02526186)

NCT ID: NCT02526186

Last Updated: 2024-03-27

Results Overview

measured daily from days 0-11.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 12 days
• Results posted on: 2024-03-27

Participant Flow

Participant milestones

Measure	Standard of Care Standard of Care only	Battlefield Auricular Acupuncture Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture
Overall Study STARTED	33	37
Overall Study COMPLETED	33	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Battlefield Auricular Acupuncture for Control of Post-partum Pain

Baseline characteristics by cohort

Measure	Standard of Care n=33 Participants Standard of Care only	Battlefield Auricular Acupuncture n=37 Participants Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	37 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 days

measured daily from days 0-11.

Outcome measures

Measure	Standard of Care n=33 Participants Standard of Care only	Battlefield Auricular Acupuncture n=37 Participants Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 5	12 # of subjects with 50% pain reduction	15 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 6	16 # of subjects with 50% pain reduction	17 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 0	0 # of subjects with 50% pain reduction	0 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 1	2 # of subjects with 50% pain reduction	6 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 2	3 # of subjects with 50% pain reduction	9 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 3	4 # of subjects with 50% pain reduction	11 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 4	8 # of subjects with 50% pain reduction	12 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 7	17 # of subjects with 50% pain reduction	21 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 8	20 # of subjects with 50% pain reduction	22 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 9	24 # of subjects with 50% pain reduction	26 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 10	25 # of subjects with 50% pain reduction	26 # of subjects with 50% pain reduction
Number of Subjects Who Achieved 50% Sustained Pain Reduction day 11	28 # of subjects with 50% pain reduction	27 # of subjects with 50% pain reduction

SECONDARY outcome

Timeframe: 12 days

morphine equivalent units (total mg)

Outcome measures

Measure	Standard of Care n=33 Participants Standard of Care only	Battlefield Auricular Acupuncture n=37 Participants Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture
Morphine Equivalent Use	88 total mg Standard Deviation 58	82 total mg Standard Deviation 113

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Battlefield Auricular Acupuncture

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

Amanda Crawford

MOMH

Phone: 7025633583

Email: amanda.j.crawford.ctr@health.mil

Results disclosure agreements

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