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

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:
NCT01301482
First received: February 18, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Acute Sore Throat
Device: 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 in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)

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


Estimated Enrollment: 33
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 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

  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 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
  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: NCT01301482

Contacts
Contact: Jill M 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, CCRP, CCRC    7026533298    jill.clark.3.ctr@us.af.mil   
Principal Investigator: David Moss, M.D.         
Sub-Investigator: Paul Crawford, 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: NCT01301482     History of Changes
Other Study ID Numbers: FWH20110009H
Study First Received: February 18, 2011
Last Updated: November 21, 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
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014