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

Acute Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01301482
• Other study ID #: FWH20110009H
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2020
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Sore Throat
• Pharyngitis

Intervention

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).

Locations

Country	Name	City	State
United States	Mike O'Callaghan Federal Hosptial	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Mike O'Callaghan Military Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain	Does ear acupuncture alone significantly reduce pain in acute sore throat?	5 months