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

NCT01301482 | Terminated Results

• 1 other identifier: FWH20110009H
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Sore Throat; Ear Acupuncture

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain on Numeric Pain Rating Scale

  Does ear acupuncture alone significantly reduce pain in acute sore throat? Measured by reduction in pain on 0-10 (10 highest pain) numeric pain rating scale.

  initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post

Study Arms (2)

battlefield auricular acupuncture

EXPERIMENTAL

Device: Ear Acupuncture

placebo

NO INTERVENTION

Interventions

Ear Acupuncture 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).

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 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

You may not qualify if:

• 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

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

Study was terminated after three subjects were recruited. 33 were predicted in protocol to be enough to analyze meaningful data, alas, only 3 were recruited. Study was no longer necessary (outmoded, outdated, science has changed)

Results Point of Contact

• Title: Amanda Crawford
• Organization: Mike O'Callaghan Military Medical Center

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

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 23, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Locations

US (1)