Trial Outcomes & Findings for Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs) (NCT NCT01301482)

Results Overview

Does ear acupuncture alone significantly reduce pain in acute sore throat? Measured by reduction in pain on 0-10 (10 highest pain) numeric pain rating scale.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post

Results posted on

2024-08-09

Participant Flow

Study was terminated after 3 subjects were recruited. Study was no longer necessary (outmoded, outdated, science has changed)

Participant milestones

Participant milestones
Measure	Battlefield Auricular Acupuncture Ear Acupuncture: Ear acupuncture utilizes up to 10 needles (see figure 6). If at any point the subject decides not to continue with the placing of the needles, the acupuncture will cease and the number of points will be documented. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero (see figures 1-5).
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Battlefield Auricular Acupuncture Ear Acupuncture: Ear acupuncture utilizes up to 10 needles (see figure 6). If at any point the subject decides not to continue with the placing of the needles, the acupuncture will cease and the number of points will be documented. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero (see figures 1-5).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Battlefield Auricular Acupuncture n=3 Participants This single arm study places ear acupuncture needles alone in patients reporting acute sore throat and to whom NSAIDs are a contraindication. Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. If at any point the subject decides not to continue with the placing of the needles, the acupuncture will cease and the number of points will be documented. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
sore throat culture taken	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post

Population: Study was terminated. Any data collected could not be meaningfully reported. Here we report initial data collected before study termination.

Does ear acupuncture alone significantly reduce pain in acute sore throat? Measured by reduction in pain on 0-10 (10 highest pain) numeric pain rating scale.

Outcome measures

Outcome measures
Measure	Battlefield Auricular Acupuncture n=3 Participants This single arm study places ear acupuncture needles alone in patients reporting acute sore throat and to whom NSAIDs are a contraindication. Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. If at any point the subject decides not to continue with the placing of the needles, the acupuncture will cease and the number of points will be documented. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero.
Reduction in Pain on Numeric Pain Rating Scale pain 15 minutes post battlefield acupuncture	1.7 units on a scale Interval 0.0 to 4.0
Reduction in Pain on Numeric Pain Rating Scale pain 6 hours post battlefield acupuncture	1.7 units on a scale Interval 1.0 to 2.0
Reduction in Pain on Numeric Pain Rating Scale pain 24 hours post battlefield acupuncture	1 units on a scale Interval 0.0 to 2.0
Reduction in Pain on Numeric Pain Rating Scale pain 48 hours post battlefield acupuncture	0 units on a scale Interval 0.0 to 0.0
Reduction in Pain on Numeric Pain Rating Scale initial pain	6 units on a scale Interval 5.0 to 7.0

Adverse Events

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

Mike O'Callaghan Military Medical Center

Phone: 7026533583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place