Trial Design
This study is a parallel, two-arm 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 (Figure 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) [28]. Results of this trial will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) Statement [29] and Template for Intervention Description and Replication (TIDieR) Checklist[30].
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. A total of 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 labeled with the participant’s group assignment. An investigator not involved with participant recruitment or data collection will create the randomization sequence with a 1:1 allocation using a random permuted block approach on Excel 2010 (Microsoft, Redmond, WA, USA) [31]. The random permuted block approach was utilized to keep intervention arms relatively equivalent throughout the data collection process. 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. Non-standard blinding techniques are often implemented in trials assessing nonpharmacological treatments and may minimize either conscious or unconscious researcher recording and reporting bias during completion and verification of the data collection forms [32].
Interventions
Standard physical therapy rehabilitation (active control group):
Both groups will receive standard post-surgical physical therapy according to guidelines developed at our institution (Appendix 1). Five physical therapy sessions, approximately 30 minutes in duration, will occur at the 24-hour initial time point and at the 48-hour, 72-hour, 1-week, and 4-week follow-up visits. During each visit, the physical therapist will expose the surgical site to check for any signs of infection and review the post-operative precautions with the patient. The patient will perform range of motion and muscle activation exercises consisting of modified pendulum exercises, active range of motion exercises for the elbow/wrist/hand, active-assisted shoulder flexion and external rotation, gentle isometric muscle activation of the rotator cuff and deltoid, and scapular muscle activation exercises. Ice and intermittent compression will be applied for control of pain and swelling, as needed. Patients utilizing these rehabilitation guidelines after shoulder stabilization surgery have demonstrated significant improvements in pain, range of motion, and function that meet established goals for progression to the next phase of rehabilitation [33].
Battlefield acupuncture (study intervention group):
Using aseptic technique (proper handwashing, personal protective equipment (PPE), and ear cleansing with an alcohol swab), auricular acupuncture using the five points specified within the BFA protocol will be administered. Each ear will potentially be punctured with ASP needles at five sequential points: Cingulate Gyrus, Thalamus, Omega 2, Point Zero and Shen-Men (Figure 2, Appendix 2). The acupuncture sequence will begin on the same side of the shoulder surgery (ipsilateral ear) 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. Additionally, self-reported current pain level will be reassessed. If the participant’s pain is above zero to one 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 the desired pain level of zero to one out of 10 is achieved or until all 10 ASP needles are placed.
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. Participants will be instructed on how to properly care for and remove the ASP needles should they become irritating. There are no documented cases of loss of treatment effect should participants remove ASP needles prematurely to their natural falling out. All participants in the study intervention group will receive BFA treatment at the initial (24-hour) time point. Repeat treatment intervention may be provided during the 48-hour, 72-hour, and 1-week follow-up visits, but will not coincide with standard physical therapy rehabilitation sessions. The decision whether BFA intervention will be provided during the follow-up visits of the intervention group participants will be left to the discretion of the treating physical therapist and preference of the patient. Treating physical therapists will take into account the patient’s current pain level and prior response to BFA. Additionally, for each participant, the number of BFA interventions executed, the number of ASP needles inserted at each intervention, and the location of each needle’s placement will be recorded for descriptive analyses. 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 certifiedon the standard BFA protocol developed by Dr. Niemtzow [18]. Participants in the intervention group 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 24-hours, 48-hours, 72-hours, 1-week, and 4-weeks after surgery. Two previous studies suggest that the greatest effect of BFA on pain occurs at one week or less [27, 34]. 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 (Figure 1).
The VAS assesses the perception of pain intensity by asking the patient to mark their level of pain along a 100mm line, where the left limit indicates no pain and the right limit indicates the worst pain imaginable [35, 36]. The VAS is a valid and reliable measure of pain intensity [35–39] with a minimal clinically important difference (MCID) of 10mm and patient acceptable symptoms state of 30mm in acute, post-operative pain [38].
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 [40]. The POMS is a valid and reliable measure of mood in athletes and sports [40, 41].
The GROC is a 15-point self-report Likert scale (-7 to +7, with -7 equaling a very great deal worse, zero equaling no change or improvement, and +7 equaling a very great deal better) of patient perceived status since the onset of treatment [42]. The GROC is valid and reliable with an MCID of two points [42], although numerous studies define major improvement as five or greater.
At each visit, the physical therapist will assess the surgical site and neurological status of the patient. The area of treatment will be examined for those patients who have received BFA. Any side effects or adverse events will be recorded in the patient’s electronic medical record and either treated or referred to an appropriate medical provider for treatment. Serious adverse events will be reported to the IRB in accordance with the approved study protocol. At the conclusion of the study, each patient’s medical record will be screened for any adverse events.
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, b = 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 data from a previous published study at the same institution [27]. 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. Four separate 2-by-5 mixed-model analyses of variance (ANOVA) with group as the between-subjects factor (BFA plus standard physical therapy rehabilitation versus standard physical therapy rehabilitation alone) and time as the repeated measure within-subjects factor (24-hours, 48-hours, 72-hours, 1-week, 4-weeks) to determine the effect of BFA on pain, medication use, self-reported improvement (GROC), and mood (POMS) over the 4-week post-operative period. Alpha will be set at 0.05 for all omnibus comparisons, which are the group*time interaction, the main effect for group (fixed factor), and the main effect for time (repeated measure). Planned pairwise comparisons will be performed to examine significant main effects for group using independent t-test, and time using paired t-tests . Alpha for planned pairwise comparisons will be corrected using the Sidak’s correction to control for family-wise type I error. The Cohen d coefficient will be used to assess effect size between pairwise comparisons. Prior to performance of the ANOVAs, all outcome measures will be assessed for normality. The appropriate non-parametric statistical tests will be used for any non-normality distributed outcomes.
When post-intervention data points are missing, data will be replaced using multiple imputation for participants who received their allocated intervention [43]. All statistical analyses will be performed with the statistical package SPSS version 26 (IBM, Chicago, IL, USA).