Acute Sore ThroatNCT01302769

Ear Acupuncture for Acute Sore Throat.

A study testing Standard treatment plus ear acupuncture in people with Acute Sore Throat, run by Mike O'Callaghan Military Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. 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?: Standard treatment plus ear acupuncture
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: Oct 2011to 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 an 11 point scale (0-10 with 10 being the worst pain)

Who cannot join

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

Show all 13Show fewer

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

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

Official title: Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.

Conditions: Acute Sore Throat
Being tested: Standard treatment plus 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.

Standard treatment plus ear acupunctureDevice
Also called Sedatelec ASP Original Gold needles
Standard treatment plus ear acupuncture

Study groups in NCT01302769
Study group	Role	What they receive
battlefield auricular acupuncture	Experimental	battlefield auricular acupuncture Receives: Device: Standard treatment plus 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
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.
Measured: 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.
Measured: 48 hours per subject
Missed Work Hours
Measured: 48 hours per subject

Timeline

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

Oct 2011Aug 2014

First posted24 Feb 2011 (estimated)
Study startOct 2011
Primary completionAug 2014
Study completionAug 2014

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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01302769
Sponsor's protocol ID: FWH20110008H
Status last verified: Feb 2024
First submitted: 18 Feb 2011
Last updated: 12 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Not permitted to share data.

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?

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All Acute Sore Throat trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT01302769
Acronym / sponsor ID: FWH20110008H
Conditions: Acute Sore Throat
Keywords: Acute Sore Throat, Ear Acupuncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Mike O'Callaghan Military HospitalUS federal agency
Study start: Oct 2011 (actual)
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 24 Feb 2011 (estimated)
Results: Posted 12 Feb 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: Standard treatment plus ear acupuncturebattlefield auricular 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 (2 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 an 11 point scale (0-10 with 10 being the worst pain)

Key exclusion criteria (13 listed)

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)

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
Standard treatment plus ear acupunctureAlso: Sedatelec ASP Original Gold needlesStandard treatment plus ear acupuncture	Device	battlefield auricular acupuncture

Primary outcome

Reduction in Pain
Time frame: 48 hours per subject
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.
Ibuprofen Doses Taken
Time frame: 48 hours per subject
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.
Missed Work Hours
Time frame: 48 hours per subject

Results and safety

Results posted to the registry on 12 Feb 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	28	27
Placebo	28	27

Primary outcome: Reduction in Pain

Time frame: 48 hours per subject. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Battlefield Auricular Acupuncture n = 27	Placebo n = 27
Pain scores (0-10) [0 minutes]	6.4 (6.0 to 6.8)	6.2 (5.7 to 6.7)
Pain scores (0-10) [15 minutes]	2.6 (1.7 to 3.5)	6.0 (5.4 to 6.6)
Pain scores (0-10) [6 hours]	2.5 (1.6 to 3.4)	4.8 (4.0 to 5.6)
Pain scores (0-10) [24 hours]]	1.9 (1.0 to 2.8)	4.1 (3.3 to 4.9)
Pain scores (0-10) [48 hours]]	1.3 (0.6 to 2.0)	2.3 (1.6 to 3.0)

Primary outcome: Ibuprofen Doses Taken

Time frame: 48 hours per subject. Mean (95% Confidence Interval). Unit: number ibuprofen doses taken

Measure	Battlefield Auricular Acupuncture n = 27	Placebo n = 27
ibuprofen doses taken (6 hours)	0.39 (0.2 to 0.58)	1.07 (0.69 to 1.45)
ibuprofen doses taken (24 hours)	1.37 (0.92 to 1.82)	2.63 (1.95 to 3.31)
ibuprofen doses taken (48 hours)	2.19 (1.44 to 2.94)	4.07 (2.9 to 5.24)

Primary outcome: Missed Work Hours

Time frame: 48 hours per subject. Mean (95% Confidence Interval). Unit: number hours missed from work

Measure	Battlefield Auricular Acupuncture n = 27	Placebo n = 27
Missed work hours [15 minutes]	0.61 (0.0 to 1.25)	1.13 (0.49 to 1.77)
Missed work hours [6 hours]	1.57 (0.66 to 2.48)	3.19 (1.91 to 4.47)
Missed work hours [24 hours]	3.04 (1.34 to 4.74)	5.48 (3.25 to 7.71)
Missed work hours [48 hours]	3.78 (1.63 to 5.93)	6.48 (3.99 to 8.97)

Adverse events

Time frame: 48 hours (per subject). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Battlefield Auricular Acupuncture	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Placebo	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): Small sample size, no sham acupuncture, subjects not blinded to treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Not permitted to share data.

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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 Standard treatment plus 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 12 Feb 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 12 Feb 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 (time frame: 48 hours per subject). The study lists 3 primary outcomes in all. 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 NCT01302769.

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 12 Feb 2024.