Back to resultsEar Acupuncture for Acute Sore Throat.
Primary Purpose
Acute Sore Throat
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard treatment plus ear acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acute Sore Throat focused on measuring Acute Sore Throat, Ear Acupuncture
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 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
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
battlefield auricular acupuncture
Outcomes
Primary Outcome Measures
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 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, ask about their missed hours from work, and ask the number of doses of ibuprofen taken. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.
Secondary Outcome Measures
Full Information
NCT ID
NCT01302769
First Posted
February 18, 2011
Last Updated
February 1, 2016
Sponsor
Mike O'Callaghan Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01302769
Brief Title
Ear Acupuncture for Acute Sore Throat.
Official Title
Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
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 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.
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
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
battlefield auricular acupuncture
Arm Type
Experimental
Arm Description
battlefield auricular acupuncture
Arm Title
placebo
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Standard treatment plus ear acupuncture
Other Intervention Name(s)
Sedatelec ASP Original Gold needles
Intervention Description
Standard treatment plus ear acupuncture
Primary Outcome Measure Information:
Title
Reduction in Pain
Description
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 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, ask about their missed hours from work, and ask the number of doses of ibuprofen taken. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.
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 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
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 AFB
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.
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