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

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.

Subjects (MOFH personnel & DoD beneficiaries)that are 18 years or older with a chief complaint of acute sore throat who have one of the inclusion criteria will be booked for appointments in the Acute Sore Throat Clinic. At the time of check-in the subject will be screened by the technician and will be asked the screening questions for exclusion criteria (See attached instrument). If the subject is eligible for inclusion into the study, the Informed Consent process will be performed and documented by someone on the study staff. The PI will have the AI or Study staffs recruit their patients to prevent any misconception of coercion. The inclusion/exclusion criteria will be verified in Armed Forces Health Longitudinal Technology Application (AHLTA). The investigator will evaluate the subject and further determine any further exclusion criteria based on exam. The subject will have adequate time to ask questions concerning the study and will sign the Informed Consent Document and HIPAA Authorization Form prior to any study-related procedures being performed. The subject will get a throat culture and will receive ear acupuncture. If throat culture is positive, patients will be notified and referred to their Primary Care Manager to be prescribed standard of care antibiotics. The ear will be cleansed with an alcohol swab prior to ear acupuncture.

Subjects will be asked 15 minutes after their treatment to assess their pain on a scale of 0-10 (with 10 being the worst pain). 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 and ask about their missed hours from work(see attached telephone data collection tool). Subjects who report back after 48 hours with unimproved sore throat will be instructed to make a same day follow up with the clinic.

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).

Subject's participation in this study is completed after 48 hours.

Patients will be instructed to have no heavy meals, excessive hot or cold foods, heavy exercise or intercourse and no alcohol for 24 hours. Ear needles will fall out on their own within the next 6 days.

We anticipate that the ear acupuncture will improve the reduction in pain by 2 points on a 10 point scale (with 10 being the worst pain). (0-10 point scale)

The risks associated with the use of ear acupuncture needles include: pain, bleeding, infection (very rare) and flare of signs and symptoms. In the event the acupuncture needles do not fall out within 6 days, patients will be instructed to come in and have them removed by one of the Investigators. In this study we are using Sedatelec ASP Original Gold needles. These acupuncture needles are sterile, gold plated semi permanent ear acupuncture needles for single use. (see figure 6) All investigators are certified in Battlefield Acupuncture and have certification in the MOFH Credentials file.

If at any time during the study, the subject decides to withdraw from the study, they can come in and have the ear acupuncture needles removed by one of the Investigators. If a subject becomes pregnant during the study, they will be withdrawn from the study and the acupuncture needles will be removed. If patients are withdrawn from the study, they will have the option to either have the acupuncture needles removed by one of the investigators or allow them to fall out on their own.

Patients must agree to take precautions to prevent pregnancy during the course of this study. The only completely reliable methods of birth control are total abstinence or surgical removal of the uterus. Other methods, such as the use of condoms, a diaphragm or cervical cap, birth control pills, IUD, or sperm killing products are not totally effective in preventing pregnancy. Also, women who are breastfeeding may not participate in this study.

The Food and Drug Administration (FDA) regulates acupuncture needles as a class II medical device because they are intended for use in the cure, mitigation, treatment, or prevention of disease in man or are intended to affect the structure or function of the body of man. The FDA regulates the acupuncture needles (see 21 CFR 880.5580), but not the practice of acupuncture itself. The needles being used are Sedatelec ASP Original Gold needles, which are approved by the FDA for use in acupuncture and will be used in accordance with their FDA approved labeling.

Inclusion:

• Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
• Male and female subjects(MOFH personnel & DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat 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
• Pregnancy
• History of gastric bypass surgery
• Known Peritonsillar abscess (PTA)
• Throat, mouth or esophageal cancer
• Chronic oral steroids use
• Minimum pain score of 5 points on a 0-10 point scale (with 10 being the worst pain)

Exclusion:

• Absence of one or more ears
• Active cellulitis of ear
• Ear anatomy precluding identification of acupuncture landmarks
• Use of Hearing Aids
• Non-English speaking