Ear Acupuncture for Post-operative Pain Associated With Ambulatory Arthroscopic Knee Surgery - A Randomized Controlled Trial

Subjects (DoD beneficiaries) that are 18 years or older with a scheduled ambulatory arthroscopic knee surgery will present for their pre-op appointment. At the time of check-in the subjects meeting the inclusion criteria, will be offered the opportunity to participate. Informed Consent and HIPAA Authorization will be obtained prior to any study-related procedures or any sedation being performed. The subject will be asked the screening questions for exclusion criteria (See attached instrument). The PI will have the AI or Study staffs recruit their patients to prevent any misconception of coercion. The subjects Armed Forces Health Longitudinal Technology Application (AHLTA) record including previous encounters, vital signs review, medication list, demographics and problems list will be reviewed by one of the investigators to confirm the inclusion/exclusion criteria have been met. The investigator will evaluate the subject and determine any further exclusion criteria based on exam. These subjects will then be randomized into two groups using a random number generator via block randomization by the Research Coordinator:

Group 1: Standard treatment alone Group 2: Standard treatment plus ear acupuncture

Subjects will be asked upon admittance to the PACU and the SDSU to answer the questions in the Data Collection Tool. Subjects will be given treatment while in the operating room and while under sedation according to their randomization group. The right and left ears will be cleansed with an alcohol swab prior to ear acupuncture. All subjects, regardless of study group, will get band aid to cover both ears. This is done to blind the orthopedic surgeon, the anesthesiologist and any nursing staff that comes in contact with the patient. Even though they are getting standard of care pain treatment, the investigators are blinding these individuals to remove any potential of bias when they are assessing a subject's pain. Subjects in both groups will be instructed to remove the band aids 24 hours after their surgery. After the subject has been discharged, phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month. These contacts will be used to assess the subject's pain level, ambulation status, doses of analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be asked the PIQ-6 Pain Impact Questionnaire.

Subjects are getting the knee arthroscopy as part of standard of care in this study. It is standard of care to have military members return to to light-duty 2 weeks after knee arthroscopy and full-duty 6 weeks after knee arthroscopy. Should the subject return to duty with the acupuncture needles still in place, this will not affect their ability to perform their duties, however, to maintain compliance with AFI 36-2903, you may want to remove the needles or place a bandage over both ears to cover the ear acupuncture needles.

Ear acupuncture utilizes up to 10 needles. 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. The subject will receive five needles intra-operatively on each ear.