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

Primary Purpose

Acute Sore Throat

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ear Acupuncture
Sponsored by
Mike O'Callaghan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Sore Throat focused on measuring Acute Sore Throat, Ear Acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mike O'Callaghan Federal Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

battlefield auricular acupuncture

placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduction in pain
Does ear acupuncture alone significantly reduce pain in acute sore throat?

Secondary Outcome Measures

Full Information

First Posted
February 18, 2011
Last Updated
August 10, 2020
Sponsor
Mike O'Callaghan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01301482
Brief Title
Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)
Official Title
Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Study is no longer necessary (outmoded, outdated, science has changed)
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mike O'Callaghan Military Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Sore Throat
Keywords
Acute Sore Throat, Ear Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
battlefield auricular acupuncture
Arm Type
Experimental
Arm Title
placebo
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Ear Acupuncture
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction in pain
Description
Does ear acupuncture alone significantly reduce pain in acute sore throat?
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Moss, M.D.
Organizational Affiliation
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Federal Hosptial
City
Nellis Air Force Base
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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