Ear Acupuncture for Acute Sore Throat.
This study is currently recruiting participants.
Verified April 2012 by Mike O'Callaghan Federal Hospital
Sponsor:
Mike O'Callaghan Federal Hospital
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302769
First received: February 18, 2011
Last updated: April 19, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Sore Throat |
Device: Standard treatment plus ear acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ear Acupuncture for Acute Sore Throat. A Randomized Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by Mike O'Callaghan Federal Hospital:
Primary Outcome Measures:
- Reduction in Pain [ Time Frame: 5 months ] [ Designated as safety issue: No ]Subjects will be randomized to recieve 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 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, ask about their missed hours from work, and ask the number of doses of ibuprofen taken. Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.
| Estimated Enrollment: | 65 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Standard treatment plus ear acupuncture
Standard treatment plus ear acupuncture
Other Name: Sedatelec ASP Original Gold needles
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion:
- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- Male and female subjects (MOFH personnel and 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 0-10 point scale (with 10 being the worst pain)
Exclusion:
- History of significant gastrointestinal bleed
- Previous documented history of stage 2 kidney disease or worse
- 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
- Allergy to Ibuprofen
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302769
Contacts
| Contact: Jennie Moss, R.N. | 7026532756 | jennie.moss@nellis.af.mil |
| Contact: David Moss, M.D. | 7026532756 | david.moss@nellis.af.mil |
Locations
| United States, Nevada | |
| Mike O'Callaghan Federal Hosptial | Recruiting |
| Nellis AFB, Nevada, United States, 89191 | |
| Contact: Jennie Moss, R.N. 7026532756 jennie.moss@nellis.af.mil | |
| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC 7026532756 jill.teixeira@nellis.af.mil | |
| Sub-Investigator: Paul Crawford, M.D. | |
| Principal Investigator: David Moss, M.D. | |
| Sub-Investigator: Heather Pickett, D.O. | |
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
| Principal Investigator: | David Moss, M.D. | Mike O'Callaghan Federal Hospital/Nellis Air Force Base |
More Information
No publications provided
| Responsible Party: | Mike O'Callaghan Federal Hospital |
| ClinicalTrials.gov Identifier: | NCT01302769 History of Changes |
| Other Study ID Numbers: | FWH20110008H |
| Study First Received: | February 18, 2011 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mike O'Callaghan Federal Hospital:
|
Acute Sore Throat Ear Acupuncture |
Additional relevant MeSH terms:
|
Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013