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Study is no longer necessary (outmoded, outdated, science has changed)
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| battlefield auricular acupuncture | Experimental |
| |
| placebo | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ear Acupuncture | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post |
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Inclusion:
The above with any one of the following:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| David Moss, M.D. | Mike O'Callaghan Federal Hospital/Nellis Air Force Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Hosptial | Nellis Air Force Base | Nevada | 89191 | United States |
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Study was terminated after 3 subjects were recruited. Study was no longer necessary (outmoded, outdated, science has changed)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study was terminated. Any data collected could not be meaningfully reported. Here we report initial data collected before study termination. | Posted | Mean | Full Range | units on a scale | initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Battlefield Auricular Acupuncture | There were 0 adverse events of any severity. Study was terminated as no longer necessary (outmoded, outdated, science has changed) |
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Study was terminated after three subjects were recruited. 33 were predicted in protocol to be enough to analyze meaningful data, alas, only 3 were recruited. Study was no longer necessary (outmoded, outdated, science has changed)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | Mike O'Callaghan Military Medical Center | 7026533583 | amanda.j.crawford.ctr@health.mil |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| sore throat culture taken | Count of Participants | Participants |
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|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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