Acute Sore Throat
Conditions
Keywords
Acute Sore Throat, Ear Acupuncture
Brief summary
The purpose of this study is to compare ear acupuncture plus standard of care versus standard therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti inflammatory medication use, hours lost from work in acute sore throat.
Interventions
DEVICEStandard treatment plus ear acupuncture
Standard treatment plus ear acupuncture
Sponsors
Mike O'Callaghan Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Male and female subjects (DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat. * Minimum pain score of 5 points on an 11 point scale (0-10 with 10 being the worst pain) Exclusion: * History of significant gastrointestinal bleed * Previous documented history of stage 2 kidney disease or worse * Known Pregnancy * History of gastric bypass surgery * Known Peritonsillar abscess (PTA) * Throat, mouth or esophageal cancer * Chronic oral steroids use * Absence of one or more ears * Active cellulitis of ear * Ear anatomy precluding identification of acupuncture landmarks * Non-English speaking * Use of Hearing Aids that preclude the use of ear acupuncture * Allergy to Ibuprofen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Pain | 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. |
| Ibuprofen Doses Taken | 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. |
| Missed Work Hours | 48 hours per subject | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Battlefield Auricular Acupuncture battlefield auricular acupuncture
Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture | 27 |
| Placebo standard of care | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Battlefield Auricular Acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Female | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 19 Participants |
| throat culture | 0 Participants | 0 Participants | 0 Participants |
| urine pregnancy test | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Ibuprofen Doses Taken
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.
Time frame: 48 hours per subject
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Battlefield Auricular Acupuncture | Ibuprofen Doses Taken | ibuprofen doses taken (6 hours) | 0.39 number ibuprofen doses taken |
| Battlefield Auricular Acupuncture | Ibuprofen Doses Taken | ibuprofen doses taken (24 hours) | 1.37 number ibuprofen doses taken |
| Battlefield Auricular Acupuncture | Ibuprofen Doses Taken | ibuprofen doses taken (48 hours) | 2.19 number ibuprofen doses taken |
| Placebo | Ibuprofen Doses Taken | ibuprofen doses taken (6 hours) | 1.07 number ibuprofen doses taken |
| Placebo | Ibuprofen Doses Taken | ibuprofen doses taken (24 hours) | 2.63 number ibuprofen doses taken |
| Placebo | Ibuprofen Doses Taken | ibuprofen doses taken (48 hours) | 4.07 number ibuprofen doses taken |
Primary
Missed Work Hours
Time frame: 48 hours per subject
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Battlefield Auricular Acupuncture | Missed Work Hours | Missed work hours [15 minutes] | 0.61 number hours missed from work |
| Battlefield Auricular Acupuncture | Missed Work Hours | Missed work hours [6 hours] | 1.57 number hours missed from work |
| Battlefield Auricular Acupuncture | Missed Work Hours | Missed work hours [48 hours] | 3.78 number hours missed from work |
| Battlefield Auricular Acupuncture | Missed Work Hours | Missed work hours [24 hours] | 3.04 number hours missed from work |
| Placebo | Missed Work Hours | Missed work hours [48 hours] | 6.48 number hours missed from work |
| Placebo | Missed Work Hours | Missed work hours [15 minutes] | 1.13 number hours missed from work |
| Placebo | Missed Work Hours | Missed work hours [6 hours] | 3.19 number hours missed from work |
| Placebo | Missed Work Hours | Missed work hours [24 hours] | 5.48 number hours missed from work |
Primary
Reduction in Pain
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.
Time frame: 48 hours per subject
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Battlefield Auricular Acupuncture | Reduction in Pain | Pain scores (0-10) [0 minutes] | 6.4 score on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain | Pain scores (0-10) [15 minutes] | 2.6 score on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain | Pain scores (0-10) [6 hours] | 2.5 score on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain | Pain scores (0-10) [48 hours]] | 1.3 score on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain | Pain scores (0-10) [24 hours]] | 1.9 score on a scale |
| Placebo | Reduction in Pain | Pain scores (0-10) [24 hours]] | 4.1 score on a scale |
| Placebo | Reduction in Pain | Pain scores (0-10) [0 minutes] | 6.2 score on a scale |
| Placebo | Reduction in Pain | Pain scores (0-10) [6 hours] | 4.8 score on a scale |
| Placebo | Reduction in Pain | Pain scores (0-10) [15 minutes] | 6.0 score on a scale |
| Placebo | Reduction in Pain | Pain scores (0-10) [48 hours]] | 2.3 score on a scale |