Acute Sore ThroatNCT01301482

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

A study testing Ear Acupuncture in people with Acute Sore Throat, run by Mike O'Callaghan Military Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Sore Throat
What is being tested?: Ear Acupuncture
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2012to Aug 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Conditions: Acute Sore Throat
Being tested: Ear Acupuncture
Keywords: Acute Sore Throat, Ear Acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ear AcupunctureDevice
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).

Study groups in NCT01301482
Study group	Role	What they receive
battlefield auricular acupuncture	Experimental	Not described Receives: Device: Ear Acupuncture
placebo	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2012Aug 2014

First posted23 Feb 2011 (estimated)
Study start1 Jan 2012
Primary completionAug 2014
Study completionAug 2014

Why it stopped: Study is no longer necessary (outmoded, outdated, science has changed)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Sore ThroatStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301482
Sponsor's protocol ID: FWH20110009H
Status last verified: Aug 2024
First submitted: 18 Feb 2011
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Sore Throat trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)
ClinicalTrials.gov ID: NCT01301482
Acronym / sponsor ID: FWH20110009H
Conditions: Acute Sore Throat
Keywords: Acute Sore Throat, Ear Acupuncture
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study is no longer necessary (outmoded, outdated, science has changed)
Enrolment: 3 participants (actual)
Lead sponsor: Mike O'Callaghan Military HospitalUS federal agency
Study start: 1 Jan 2012 (actual)
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 23 Feb 2011 (estimated)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
battlefield auricular acupuncture	Experimental	Device: Ear Acupuncture
placebo	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)
Allergy to Non-Steroidal Anti-inflammatory agents (NSAIDs)
History of significant gastrointestinal bleed
Previous documented history of stage 2 kidney disease or worse

Key exclusion criteria (8 listed)

Absence of one or more ears
Known Pregnancy
Known Peritonsillar abscess (PTA)
Throat, mouth or esophageal cancer
Active cellulitis of ear

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ear AcupunctureEar 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).	Device	battlefield auricular acupuncture

Primary outcome

Reduction in Pain on Numeric Pain Rating Scale
Time frame: initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post
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.

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Battlefield Auricular Acupuncture	3	2

Primary outcome: Reduction in Pain on Numeric Pain Rating Scale

Time frame: initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post. Mean (Full Range). Unit: units on a scale

Measure	Battlefield Auricular Acupuncture n = 3
initial pain	6 (5 to 7)
pain 15 minutes post battlefield acupuncture	1.7 (0 to 4)
pain 6 hours post battlefield acupuncture	1.7 (1 to 2)
pain 24 hours post battlefield acupuncture	1 (0 to 2)
pain 48 hours post battlefield acupuncture	0 (0 to 0)

Population analysed: Study was terminated. Any data collected could not be meaningfully reported. Here we report initial data collected before study termination.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Battlefield Auricular Acupuncture	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): 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)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Moss, M.D. principal investigator

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ear Acupuncture in people with Acute Sore Throat, run by Mike O'Callaghan Military Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Pain on Numeric Pain Rating Scale (time frame: initial, 15 minute post, 6 hours post, 24 hours post, 48 hours post). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01301482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.