Clinical trial: Effects of External Ear Stimulation on Pain Perception and Mood (NCT02821741)

Eligibility criteria:
-  INCLUSION CRITERIA:

        All subjects must be:

          1. between 18 and 50 years old.

          2. fluent in English.

          3. able to provide written informed consent.

        EXCLUSION CRITERIA:

        Overall exclusion criteria for the study

          1. Unable to comply with study procedures or visits (including inability to schedule the
             second session within 7 days of the first session).

          2. Is pregnant or breastfeeding.

          3. Has ears with indiscernible structures (e.g., cymba conchae, earlobe) due to
             congenital malformations, accidents, or physical alterations (e.g., 'gauge', cartilage
             piercing).

          4. Has a dermatological condition such as scars or burns, or has had a tattoo in the
             testing region within the previous four weeks that might influence cutaneous
             sensibility.

          5. Women who consume more than 7 alcoholic beverages per week, and men who consume more
             than 14 drinks per week.

          6. Has a current chronic pain condition or has had chronic pain in the past year (painful
             condition lasting more than six months).

          7. Has a major medical condition, such as kidney, liver, cardiovascular, autonomic,
             pulmonary, or neurological problems (e.g., epilepsy) or a chronic systemic disease
             (e.g., diabetes).

          8. Has or had psychiatric disorders such as major depression, major anxiety-related
             problems, post-traumatic stress syndrome, bipolar disorder, psychosis, or alcohol or
             substance abuse disorders as identified by the MINI International Neuropsychiatric
             Interview questionnaire, which will be administered as part of the screening
             procedure.

          9. Has a medical condition potentially affecting cardiac functioning (e.g. arrhythmias,
             bradycardia [<60 beats per min; determined during screening]) or Raynaud s Disease or
             other medical condition affecting peripheral vascular sensitivity.

         10. Is actively taking medications that are known to interfere with current measurements
             of pain or autonomic function. These include but are not limited to: opioids,
             antidepressants (such as tricyclic antidepressants, selective serotonin reuptake
             inhibitors, and serotonin norepinephrine reuptake inhibitors), anticonvulsants
             (including gabapentin and pregabalin), and blood pressure medications (including
             beta-blockers, calcium channel blockers, and ACE inhibitors). Participants who have
             used such medications in the last three months must have ceased taking them for at
             least one month or three medication half-lives (whichever is longer) in order to be
             included.

         11. Baseline heat pain threshold exceeds 46 degrees C (to be determined after consent).

         12. Has ever had acupuncture in or around any area of the ears.

         13. NIH employees are subordinates, relatives, or co-workers of the investigators, or
             NCCIH DIR employees.

        Exclusion criteria for individual study session*

          1. Has consumed alcohol within 24 hours, shows signs of alcohol withdrawal syndrome, or
             has behavioral signs of intoxication.

          2. Has exercised or eaten within two hours of testing session.

          3. Used nicotinic substances (e.g., tobacco, gum, 'e-cigarette') within 2 hours of
             testing.

          4. Used topical pain-relieving creams in the testing area (e.g. methylsalicylate,
             capsaicin) within 24 hours of testing.

          5. Used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen),
             acetaminophen, naproxen, sumatriptan within 3 days of testing.

               -  To be determined during the pre-session screening. Participants that cannot
                  refrain from these activities may have their session rescheduled up to two times.
                  If the participant is found non-compliant during the second rescheduled
                  appointment, he or she will be excluded from the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment