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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| battlefield auricular acupuncture | Experimental | battlefield auricular acupuncture |
|
| placebo | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment plus ear acupuncture | Device | Standard treatment plus ear acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours per subject |
| 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. | 48 hours per subject |
| Missed Work Hours | 48 hours per subject |
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Inclusion:
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 |
Not permitted to share data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Battlefield Auricular Acupuncture | battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture |
| FG001 | Placebo | standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
28 were initially in study. Each arm lost one subject to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Battlefield Auricular Acupuncture | battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture |
| BG001 | Placebo | standard of care |
| 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 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 48 hours per subject |
|
48 hours (per subject)
No difference.
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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 | battlefield auricular acupuncture Standard treatment plus ear acupuncture: Standard treatment plus ear acupuncture |
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Small sample size, no sham acupuncture, subjects not blinded to treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | 99MDG Regional Clinical Investigation Program | 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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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Control- 1 patient lost to follow up Intervention- 1 patient lost to follow up | Count of Participants | Participants |
|
| throat culture | If throat culture is positive, patients will be notified and referred to their Primary Care Manager to be prescribed standard of care antibiotics | Count of Participants | Participants |
|
| urine pregnancy test | If there is a chance that the subject could be pregnant, they will be sent for a urine pregnancy test (15-20 mls or approximately 2-3 teaspoons of urine). | Count of Participants | Participants |
|
| Placebo |
standard of care |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | number ibuprofen doses taken | 48 hours per subject |
|
|
|
| Primary | Missed Work Hours | Posted | Mean | 95% Confidence Interval | number hours missed from work | 48 hours per subject |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo | standard of care | 0 | 27 | 0 | 27 | 0 | 27 |
Study takes place at military hospital with DoD active duty, veterans, and beneficiaries. Publishing of aggregate or simply deidentified data is prohibited.
| ibuprofen doses taken (48 hours) |
|
| Missed work hours [24 hours] |
|
| Missed work hours [48 hours] |
|