Acute Sore Throat
Conditions
Keywords
Acute Sore Throat, Ear Acupuncture
Brief summary
The purpose of this study is to assess the effect of ear acupuncture alone in subjects with a contraindication to anti-inflammatory medications in the reduction of pain and hours lost from work in acute sore throat.
Interventions
DEVICEEar 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).
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 a 11 point scale (0-10 with 10 being the worst pain) The above with any one of the following: * Allergy to Non-Steroidal Anti-inflammatory agents (NSAIDs) * History of significant gastrointestinal bleed * Previous documented history of stage 2 kidney disease or worse * History of gastric bypass surgery * Chronic oral steroids use Exclusion: * Absence of one or more ears * Known Pregnancy * Known Peritonsillar abscess (PTA) * Throat, mouth or esophageal cancer * Active cellulitis of ear * Ear anatomy precluding identification of acupuncture landmarks * Use of Hearing Aids that preclude the use of ear acupuncture * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Pain on Numeric Pain Rating Scale | initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post | 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. |
Countries
United States
Participant flow
Recruitment details
Study was terminated after 3 subjects were recruited. Study was no longer necessary (outmoded, outdated, science has changed)
Participants by arm
| Arm | Count |
|---|---|
| Battlefield Auricular Acupuncture 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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Battlefield Auricular Acupuncture |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
| sore throat culture taken | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Reduction in Pain on Numeric Pain Rating Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Battlefield Auricular Acupuncture | Reduction in Pain on Numeric Pain Rating Scale | initial pain | 6 units on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain on Numeric Pain Rating Scale | pain 15 minutes post battlefield acupuncture | 1.7 units on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain on Numeric Pain Rating Scale | pain 6 hours post battlefield acupuncture | 1.7 units on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain on Numeric Pain Rating Scale | pain 24 hours post battlefield acupuncture | 1 units on a scale |
| Battlefield Auricular Acupuncture | Reduction in Pain on Numeric Pain Rating Scale | pain 48 hours post battlefield acupuncture | 0 units on a scale |