Trial Outcomes & Findings for Ear Acupuncture for Acute Sore Throat. (NCT NCT01302769)

Results Overview

Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture. Subjects will be asked 15 minutes after their treatment to assess their pain on a likert scale of 0-10. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to assess their pain level. Scale: 11-point scale of 0-10 with 10 being the worst pain. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

48 hours per subject

Results posted on

2024-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Battlefield Auricular Acupuncture battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture	Placebo standard of care
Overall Study STARTED	28	28
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Battlefield Auricular Acupuncture battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture	Placebo standard of care
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Battlefield Auricular Acupuncture n=27 Participants battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture	Placebo n=27 Participants standard of care	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=93 Participants	27 Participants n=4 Participants	54 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants • Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up	20 Participants n=4 Participants • Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up	35 Participants n=27 Participants • Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up
Sex: Female, Male Male	12 Participants n=93 Participants • Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up	7 Participants n=4 Participants • Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up	19 Participants n=27 Participants • Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up
throat culture	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
urine pregnancy test	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 48 hours per subject

Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture. Subjects will be asked 15 minutes after their treatment to assess their pain on a likert scale of 0-10. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to assess their pain level. Scale: 11-point scale of 0-10 with 10 being the worst pain. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.

Outcome measures

Outcome measures
Measure	Battlefield Auricular Acupuncture n=27 Participants battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture	Placebo n=27 Participants standard of care
Reduction in Pain Pain scores (0-10) [0 minutes]	6.4 score on a scale Interval 6.0 to 6.8	6.2 score on a scale Interval 5.7 to 6.7
Reduction in Pain Pain scores (0-10) [15 minutes]	2.6 score on a scale Interval 1.7 to 3.5	6.0 score on a scale Interval 5.4 to 6.6
Reduction in Pain Pain scores (0-10) [6 hours]	2.5 score on a scale Interval 1.6 to 3.4	4.8 score on a scale Interval 4.0 to 5.6
Reduction in Pain Pain scores (0-10) [24 hours]]	1.9 score on a scale Interval 1.0 to 2.8	4.1 score on a scale Interval 3.3 to 4.9
Reduction in Pain Pain scores (0-10) [48 hours]]	1.3 score on a scale Interval 0.6 to 2.0	2.3 score on a scale Interval 1.6 to 3.0

PRIMARY outcome

Timeframe: 48 hours per subject

Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to ask the number of doses of ibuprofen taken.

Outcome measures

Outcome measures
Measure	Battlefield Auricular Acupuncture n=27 Participants battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture	Placebo n=27 Participants standard of care
Ibuprofen Doses Taken ibuprofen doses taken (6 hours)	0.39 number ibuprofen doses taken Interval 0.2 to 0.58	1.07 number ibuprofen doses taken Interval 0.69 to 1.45
Ibuprofen Doses Taken ibuprofen doses taken (24 hours)	1.37 number ibuprofen doses taken Interval 0.92 to 1.82	2.63 number ibuprofen doses taken Interval 1.95 to 3.31
Ibuprofen Doses Taken ibuprofen doses taken (48 hours)	2.19 number ibuprofen doses taken Interval 1.44 to 2.94	4.07 number ibuprofen doses taken Interval 2.9 to 5.24

PRIMARY outcome

Timeframe: 48 hours per subject

Outcome measures

Outcome measures
Measure	Battlefield Auricular Acupuncture n=27 Participants battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture	Placebo n=27 Participants standard of care
Missed Work Hours Missed work hours [15 minutes]	0.61 number hours missed from work Interval 0.0 to 1.25	1.13 number hours missed from work Interval 0.49 to 1.77
Missed Work Hours Missed work hours [6 hours]	1.57 number hours missed from work Interval 0.66 to 2.48	3.19 number hours missed from work Interval 1.91 to 4.47
Missed Work Hours Missed work hours [24 hours]	3.04 number hours missed from work Interval 1.34 to 4.74	5.48 number hours missed from work Interval 3.25 to 7.71
Missed Work Hours Missed work hours [48 hours]	3.78 number hours missed from work Interval 1.63 to 5.93	6.48 number hours missed from work Interval 3.99 to 8.97

Adverse Events

Battlefield Auricular Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

99MDG Regional Clinical Investigation Program

Phone: 7026533583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study takes place at military hospital with DoD active duty, veterans, and beneficiaries. Publishing of aggregate or simply deidentified data is prohibited.
Publication restrictions are in place

Restriction type: OTHER