Ear Acupuncture for Acute Sore Throat.

NCT01302769 | Completed Results

• 1 other identifier: FWH20110008H
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Sore Throat

Keywords

Acute Sore Throat; Ear Acupuncture

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

battlefield auricular acupuncture

EXPERIMENTAL

battlefield auricular acupuncture

Device: Standard treatment plus ear acupuncture

placebo

NO INTERVENTION

Interventions

Standard treatment plus ear acupuncture DEVICE

Standard treatment plus ear acupuncture

Also known as: Sedatelec ASP Original Gold needles

battlefield auricular acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Hosptial

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Limitations and Caveats

Small sample size, no sham acupuncture, subjects not blinded to treatment.

Results Point of Contact

• Title: Amanda Crawford
• Organization: 99MDG Regional Clinical Investigation Program

amanda.j.crawford.ctr@health.mil

7026533583

Study Officials

• David Moss, M.D.

  Mike O'Callaghan Federal Hospital/Nellis Air Force Base

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 12, 2024
• Results First Posted: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)