Ear Acupuncture for Acute Sore Throat.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302769
First received: February 18, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Acute Sore Throat
Device: Standard treatment plus ear acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • Reduction in Pain [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 65
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: battlefield auricular acupuncture
battlefield auricular acupuncture
Device: Standard treatment plus ear acupuncture
Standard treatment plus ear acupuncture
Other Name: Sedatelec ASP Original Gold needles
No Intervention: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302769

Contacts
Contact: Jill Clark, MBA/HCM, CCRP, CCRC 7026533298 jill.clark.3.ctr@us.af.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Hosptial Recruiting
Nellis AFB, Nevada, United States, 89191
Contact: Jill M Clark, MBA/HCM, CCRC, CCRP    7026533298    jill.clark.3.ctr@us.af.mil   
Sub-Investigator: Paul Crawford, M.D.         
Principal Investigator: David Moss, M.D.         
Sub-Investigator: Heather Pickett, D.O.         
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
Principal Investigator: David Moss, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302769     History of Changes
Other Study ID Numbers: FWH20110008H
Study First Received: February 18, 2011
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Mike O'Callaghan Federal Hospital:
Acute Sore Throat
Ear Acupuncture

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014