Ear Acupuncture for Acute Sore Throat.

NCT ID: NCT01302769

Last Updated: 2024-02-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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battlefield auricular acupuncture

battlefield auricular acupuncture

Group Type EXPERIMENTAL

Standard treatment plus ear acupuncture

Intervention Type DEVICE

Standard treatment plus ear acupuncture

placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Standard treatment plus ear acupuncture

Standard treatment plus ear acupuncture

Intervention Type DEVICE

Other Intervention Names

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Sedatelec ASP Original Gold needles

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mike O'Callaghan Military Hospital

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Moss, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Locations

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Mike O'Callaghan Federal Hosptial

Nellis Air Force Base, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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FWH20110008H

Identifier Type: -

Identifier Source: org_study_id

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