Ear Acupuncture for Acute Sore Throat.

Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Acute Sore Throat
• Intervention / Treatment: Device: Standard treatment plus ear acupuncture

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Nellis Air Force Base, Nevada, United States, 89191
      • Mike O'Callaghan Federal Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: placebo
Experimental: battlefield auricular acupuncture	Device: Standard treatment plus ear acupuncture; Standard treatment plus ear acupuncture; Other Names: Sedatelec ASP Original Gold needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Pain	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 likert 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. Scale: 11-point scale of 0-10 with 10 being the worst pain. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.	48 hours per subject
Ibuprofen Doses Taken	Subjects will be randomized to receive either standard treatment alone or standard treatment plus ear acupuncture. After the subject has left the clinic, phone calls will be made at 6 hours, 24 hours and 48 hours to ask the number of doses of ibuprofen taken.	48 hours per subject
Missed Work Hours		48 hours per subject

Collaborators and Investigators

• Sponsor: Mike O'Callaghan Military Hospital
• Investigators: Principal Investigator: David Moss, M.D., Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimated): February 24, 2011

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acute Sore Throat; Ear Acupuncture
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: FWH20110008H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not permitted to share data.