Battlefield Acupuncture Following Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.

Official Title
-----------------
The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial

Conditions
-----------------
Shoulder Injuries, Pain, Postoperative, Acupuncture, Ear, Pain Management

Intervention / Treatment
-----------------
* Procedure: Battlefield Acupuncture
* Procedure: Standard post-surgical rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 17-55 Department of Defense beneficiaries (17 only if an emancipated cadet at the U.S. Military Academy) Prior to or within 48 hours post shoulder stabilization surgery Prior to or within 48 hours post rotator cuff repair surgery Exclusion Criteria: Self-reported pregnancy History of blood borne pathogens, infectious disease, or active infection History of metal allergy History of bleeding disorders or currently taking anti-coagulant medications Participants who are not fluent in English

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. | Procedure: Battlefield Acupuncture<br>* Battlefield Acupuncture (BFA), an auricular acupuncture protocol developed in 2001 by Dr. Niemtzow (Ret. Colonel, USAF), is widely used among civilian and military medical providers to treat pain. Participants in the Experimental Group will receive BFA in addition to standard post-surgical rehabilitation up to four times following their shoulder surgery: 24-hours, 48-hours, 72-hours, and 1-week post-surgery.<br>|
| Active Comparator: Control Group<br>Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery. | Procedure: Standard post-surgical rehabilitation<br>* Participants will receive rehabilitation and will perform a home exercise program in accordance with the standard post-operative shoulder protocol. Participants will be asked to record compliance on an exercise log.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst overall pain assessed by Visual Analogue Scale (VAS) | Worst pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | 72 hours, 1 week | 
| Average 24-hour pain assessed by Visual Analogue Scale (VAS) | Average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | 72 hours, 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire | The POMS consists of 65 measures of mood organized into 6 mood scales: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Individual scales are combined to achieve the mood disturbance score (MDS), an aggregate indicator of overall mood. A greater MDS value indicates greater mood disturbance. | 72 hours, 1 week, 4 weeks | 
| Medication Use | Daily opioid, NSAID, and Acetaminophen use | 1 week, 4 weeks | 
| Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS) | Worst pain intensity and average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | 4 weeks |