Trial Design
This study is a single-blind randomized clinical trial. All participants will complete five study sessions following surgery: 24-hours, 48-hours, 72-hours, 1-week, and 4-weeks post-surgery (Fig. 1). Participants will receive an email the day prior to each study session to promote retention and compliance. Data collection began in November 2019 and will continue for four years. All components of the study will be completed at the U.S. Military Academy at West Point, New York. The current Standard Protocol Items: Recommended for Interventional Trials (SPIRIT) guidelines for creating protocols for randomized clinical trials were followed (Supplemental Materials)[22]. Results of this trial will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) Statement[23] and Template for Intervention Description and Replication (TIDieR) Checklist[24].
Participants and Study Setting
Participants will be recruited from the population of patients presenting to the Arvin Cadet Physical Therapy Clinic and the Keller Army Community Hospital (KACH) Physical Therapy and Orthopedic Clinics prior to and status-post shoulder stabilization surgery. 105 male and female Department of Defense (DoD) beneficiaries, ages 17–55 will be recruited for the study. A 15% drop-out rate is anticipated, which will result in at least 90 patients completing the study, with 45 patients per treatment group. On average KACH orthopedic surgeons perform eight shoulder stabilization surgeries monthly, suggesting the recruitment goal is feasible.
Inclusion Criteria:
-
DoD beneficiaries age 18 to 55 years old (17 if cadet)
-
Prior to or within 24 hours post shoulder stabilization surgery
-
Self-reported pain rating of at least 2 out of 10 on a numerical pain rating scale (NPRS)
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 not fluent in English
Randomization/Allocation/Blinding
Participants will be screened prior to consent as part of routine clinical care by the investigative team during the first post-operative visit, 24 hours after surgery. Those meeting criteria for inclusion will be informed as to the need and purpose of the research and invited to participate. Study participants will complete informed consent followed by a baseline examination (Supplemental Materials). Consenting participants will be randomized into one of two groups via a concealed allocation process; the control group (standard physical therapy rehabilitation) or the intervention group (BFA plus a standard physical therapy rehabilitation). Following informed consent and baseline examination, a second investigator blinded to the baseline examination will open a sealed envelope containing a folded index card labelled with the participant’s group assignment. The randomization sequence will be created with a 1:1 allocation using random block sizes of five on Excel 2010 (Microsoft, Redmond, WA, USA) by an investigator not involved with participant recruitment or data collection. Group assignment will be recorded with a unique participant identifier and secured in a separate folder until completion of all data collection through the final follow-up.
Participants and the treating physical therapists will not be blinded to group assignment. Verification of the medication log by the outcome assessor may be another source of bias. Outcome assessors who record pain, self-report function, and mood surveys, perform data reduction, and perform data analysis will be blinded to the participants’ treatment group. Participants frequently require clarification of outcome measure instructions during completion of data collection forms and may require additional assistance if the surgery is performed on their dominant extremity. Participants will interact with the outcome assessor and complete data collection forms behind a closed curtain, where the outcome assessor is not able to see the patient. Such blinding should minimize either conscious or unconscious researcher recording and reporting bias during completion and verification of the data collection forms.
Interventions
Standard physical therapy rehabilitation (active control group):
Both groups will receive standard postsurgical physical therapy (Appendix 1) with therapeutic exercises that will be focused on range of motion and muscle activation.
Battlefield acupuncture (study intervention group):
Using aseptic technique (proper hand washing, personal protective equipment (PPE), and ear cleansing with an alcohol swab), auricular acupuncture using the five points within the BFR protocol will be used until the participant reports zero to one out of 10 pain on a Numerical Pain Rating Scale (NPRS). Each ear will be punctured with ASP needles at five sequential points: Cingulate Gyrus, Thalamus, Omega 2, Point Zero and Shen-Men (Fig. 2, Appendix 2). The acupuncture sequence will begin on the same side of the shoulder surgery and begin at the Cingulate Gyrus point. Following each ASP needle placement, the participant will be asked to stand and move/walk for at least 30 seconds while being monitored for any side effects, including light headedness, dizziness/loss of balance or nausea. Self-reported current pain level will be reassessed. If the participant’s pain is above zero out of 10 on the NPRS, the contralateral ear will be punctured with the ASP needle in the Cingulate Gyrus. ASP needle application will continue, alternating between ipsilateral and contralateral ears in order through the remaining four points, until a desired pain level of zero to one out of 10 is achieved.
There is no standard time for the ASP needles to remain in the participant’s ears, but they may remain up to 3–5 days as they naturally work their way out of the skin. There are no documented cases of loss of treatment effect should participants remove ASP needles premature to their natural falling off. Repeat treatment may be provided during follow-up visits and is left to the discretion of the treating physical therapist and preference of the patient. If ASP needles remain in place at follow-up visits and the patient requests additional treatment, additional ASP needles will be placed adjacent to locations used previously.
All BFA treatments will be performed by investigators trained and certified investigators on the standard BFA protocol developed by Dr. Niemtzow[14]. Participants will continue to receive the standard of care in accordance with the post-operative protocol between study follow-up visits.
Outcome Measures
Demographic characteristics will be recorded and include sex, age, ethnicity, military demographics, height, weight, and surgical history. The primary outcome measure will be pain (average and worst pain over the past 24 hours, assessed on the Visual Analogue Scales [VAS]) at 48-hours, 72-hours, 1-week, and 4-weeks after surgery. Secondary outcome measures will be medication use (opioids and non-opioid medications), patient self-reported mood (Profile of Mood States [POMS]), and patient self-reported improvement (Global Rating of Change Scale [GROC]). All participants will complete all outcome measures at five post-surgical timepoints: 24-hours, 48-hours, 72-hours, 1-week, and 4-weeks (Fig. 1).
The VAS assesses the perception of pain intensity by asking the patient to mark their level of pain along a 100 mm line, where the left limit indicates no pain and the right limit indicates the worst pain imaginable[25, 26]. The VAS is a valid and reliable measure of pain intensity [25–29] with a minimal clinically important difference (MCID) of 10 mm and patient acceptable symptoms state of 30 mm in acute, post-operative pain[28].
The POMS is a 40-item questionnaire designed to measure the transient emotional states of tension-anxiety, depression-dejection, fatigue-inertia, vigor-activity, confusion-bewilderment, and anger-hostility in sports and other settings[30]. The POMS is a valid and reliable measure of mood in athletes and sports[30, 31].
The GROC is a 15-point self-report Likert scale (-7 to + 7, with − 7 equaling a very great deal worse, 0 equaling no change or improvement, and + 7 equaling a very great deal better) of patient perceived status since the onset of treatment[32]. The GROC is valid and reliable with a MCID of two points[32], although numerous studies define major improvement as five or greater.
Data Analysis
An a priori power analysis was performed using G*Power, version 3.1.9.2 (Heinrich-Heine-Universitat Dusseldorf, Dusseldorf, Germany) with α = 0.05, β = 0.80, and an effect size of 0.6 (change in VAS worst pain between 24-hours and 1-week post-surgery), resulting in a required sample of 90 participants. The effect size was determined through examination of previously collected pilot data at the same institution[21]. To account for a potential drop-out rate of 15%, a total of 105 participants will be enrolled.
Descriptive statistics, including measures of central tendency and dispersion, will be calculated for demographic data. Frequency distributions will be estimated for categorical data. The primary aim, the effect of BFA on acute post-operative pain (average and worst pain assessed by VAS), will be examined with a 2-by-2 mixed-model analysis of variance (ANOVA), with intervention group as the between-subjects factor (BFA plus standard physical therapy rehabilitation versus standard physical therapy rehabilitation alone) and time as the within-subjects factor (48-hours and 72-hours). An additional 2-by-5 mixed-model ANOVA with intervention group as the between-subjects factor and time as the within-subjects factor (24-hours, 48-hours, 72-hours, 1-week, 4-weeks) to determine the effect of BFA on medication use, self-reported improvement (GROC), and mood (POMS) over a 4-week post-operative period. The effect of BFA on acute versus subacute post-operative pain will be assessed using a 2-by-2 mixed-model ANOVA with intervention group as the between-subjects factor and time (1-weeks and 4-weeks) as the within-subjects factor. Alpha will be set at 0.05 for all omnibus comparisons. Planned pairwise comparisons will be performed to examine the differences between baseline and follow-up periods, using the Sidak’s test to control for family-wise type I error. The Cohen d coefficient will be used to assess effect size.
When post-intervention data points are missing, data will be replaced using multiple imputation for participants who received their allocated intervention[33]. All statistical analyses will be performed with the statistical package SPSS version 26 (IBM, Chicago, IL, USA).