Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)

August 6, 2024 updated by: Mike O'Callaghan Military Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Federal Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: battlefield auricular acupuncture
Device: 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).
No Intervention: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Pain on Numeric Pain Rating Scale
Time Frame: 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.
initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: David Moss, M.D., Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimated)

February 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20110009H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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