Shoulder Injuries, Pain, Postoperative, Acupuncture, Ear, Pain Management
Conditions
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.
Interventions
PROCEDUREBattlefield Acupuncture
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.
PROCEDUREStandard post-surgical rehabilitation
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.
Sponsors
Uniformed Services University of the Health Sciences
Keller Army Community Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst overall pain assessed by Visual Analogue Scale (VAS) | 72 hours, 1 week | 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. |
| Average 24-hour pain assessed by Visual Analogue Scale (VAS) | 72 hours, 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire | 72 hours, 1 week, 4 weeks | 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. |
| Medication Use | 1 week, 4 weeks | Daily opioid, NSAID, and Acetaminophen use |
| Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS) | 4 weeks | 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. |
Countries
United States
Outcome results
None listed