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

NCT ID: NCT01301482

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2014-08-31

Brief 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.

Conditions

Acute Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

battlefield auricular acupuncture

Group Type: EXPERIMENTAL

Ear Acupuncture

Intervention Type: DEVICE

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).

placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Moss, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Locations

Mike O'Callaghan Federal Hosptial

Nellis Air Force Base, Nevada, United States

Countries

United States

Other Identifiers

FWH20110009H

Identifier Type: -

Identifier Source: org_study_id