Ear Acupuncture for Acute Sore Throat.

Acute Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302769
• Other study ID #: FWH20110008H
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: August 2014

Study information

• Verified date: February 2024
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• 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 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

Related Conditions & MeSH terms

• Acute Sore Throat
• Pharyngitis

Intervention

Device:
• Standard treatment plus ear acupuncture
Standard treatment plus ear acupuncture

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	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
Primary	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
Primary	Missed Work Hours		48 hours per subject