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

Mike O'Callaghan Military Hospital

Status: Terminated

Conditions: Acute Sore Throat

Treatments: Device: Ear Acupuncture

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01301482

FWH20110009H

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

battlefield auricular acupuncture

Experimental group

Treatment:

Device: Ear Acupuncture

placebo

No Intervention group