Battlefield Acupuncture Following Shoulder Surgery

Keller Army Community Hospital95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Shoulder Injuries Pain, Postoperative Acupuncture, Ear Pain Management

Interventions

Battlefield AcupuncturePROCEDURE

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.

Standard post-surgical rehabilitationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 17 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 72 hours, 1 week

Secondary Outcomes

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.

Time frame: 72 hours, 1 week, 4 weeks

Medication Use

Daily opioid, NSAID, and Acetaminophen use

Time frame: 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.

Time frame: 4 weeks