| Registry | NCT01301482 |
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| Status | Terminated - Study is no longer necessary (outmoded, outdated, science has changed) |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, single group, masking: none, treatment |
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| Enrollment | 3 (Actual) |
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| Sponsor | Mike O'Callaghan Military Hospital (Fed) |
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| Conditions | Acute Sore Throat |
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| Interventions | Ear Acupuncture (Device) |
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| Dates | start 2012-01-01, primary completion 2014-08-01, completion 2014-08-01, first posted 2011-02-23, last updated 2024-08-09 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Acute Sore Throat All trials of Ear Acupuncture
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| battlefield auricular acupuncture | Experimental | Device: Ear Acupuncture | |
| placebo | No intervention | | |
- 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).
+Outcome measures
Primary outcomes
- 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.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Battlefield Auricular Acupuncture |
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| Started | 3 |
| Completed | 2 |
| Not completed | 1 |
Outcome results
- Reduction in Pain on Numeric Pain Rating Scale (Primary), Mean, units on a scale: Battlefield Auricular Acupuncture 6 (5 to 7)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Battlefield Auricular Acupuncture | 0/3 (0.0%) | 0/3 (0.0%) | 0/3 (0.0%) |
Limitations and caveats: 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)
+Locations (1)
| Facility | City | Country | Status |
|---|
| Mike O'Callaghan Federal Hosptial | Nellis Air Force Base, Nevada | United States | |
+Investigators
- David Moss, M.D., Principal investigator, Mike O'Callaghan Federal Hospital/Nellis Air Force Base