EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
Phase: NA
Conditions: Shoulder Dislocation
Sponsor: Virginia Commonwealth University

 
 
Title: EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized 
Trial 
 
NCT #: NCT04820491 
 
Document date: July 17, 2020 
 
Document Type: Protocol and Statistical Analysis Plan 
 
 
 

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EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter 
Prospective Randomized Trial 
 
Principal Investigator: 
Jordan Tozer 
 
Other Investigators: 
David Evans, MD: Key Study Personnel 
Jacob Wayman: Key Study Personnel 
 
Institutional affiliations: 
VCU Health 
Cleveland Clinic Akron General 
 
 
I. 
BACKGROUND AND SIGNIFICANCE 
 
The shoulder joint is the most common joint requiring reduction by 
emergency physicians, accounting for almost 50% of all major joint dislocations.1 
This presentation amounts to roughly 200,000 emergency department visits each 
year. 2 The estimated incidence of shoulder dislocations in the United States is 23.9 
per 100,000 person/year with male gender and young age being the two largest risk 
factors. 2 The current standard of care for this presentation is to identify the 
dislocation on both physical exam and X-ray and then confirm the success of 
reduction by physical exam and X-ray following reduction. X-ray imaging does 
expose the patient to radiation, although minimally when as compared to other 
radiation-based imaging. However it is now being recommended by one study that 
pre and post-reduction X-rays can be omitted to help decrease the length of stay, 
radiation exposure and overall cost.  The recommendation is that X-ray can be 
replaced with the application of ultrasonography. 3 The aim of this study is to 
further assess the efficacy of point of care ultrasonography to diagnose and gauge 
the reduction success of shoulder dislocations in an emergency department setting.  
With increasing availability and utilization of ultrasound, multiple studies 
suggest that this imaging modality can play an integral role in the diagnosis of and 
reduction confirmation for shoulder dislocations. 4-8 Studies assessing accuracy of 
diagnosis deemed ultrasound to be 100% specific and 100% sensitive. 9-10 A recent 
meta-analysis concluded that ultrasound is highly sensitive and specific for shoulder 
reductions, dislocations, and associated fractures. 9 Another study identified that 
diagnostic radiographs increased patient length of stay by 30 minutes. 11 The ease, 
efficacy, and timeliness of ultrasound has the potential to decrease the length of stay 
for emergency department patients. A WJEM systematic review recommended that 
“while the data is supportive of the use of ultrasound for the diagnosis of shoulder 
dislocation, further studies are needed prior to routine implementation. Future 
studies should compare the different techniques to determine which is most 

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accurate, record performance time for the ultrasound, include more data on 
posterior dislocations, include more data on fracture identification, and validate one 
of the above techniques with increased sample sizes”. 8 
Overall, the utilization of point of care ultrasonography has been well studied 
and has recurrently shown to be useful and efficacious.  The goal of this study is to 
expand on this literature as it pertains to utilization in the emergency department 
setting. The study will evaluate the impact of POCUS on length of stay, x-ray 
reduction, and satisfaction of patients presenting with suspected shoulder 
dislocation. 
  
II. 
STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES 
 
The primary objective of this study is to determine if there is any difference in the 
length of stay between patients with shoulder dislocation who are treated with 
traditional x-ray imaging for diagnosis and reduction confirmation and those that 
are treated with POCUS for diagnosis and reduction confirmation. 
 
Hypothesis: The use of POCUS for shoulder dislocation and reduction 
confirmation will reduce the length of stay for ED patients. 
 
The secondary objectives of this study include evaluating patient satisfaction, 
providing a cost analysis, time to diagnosis, confirmation of reduction, and volume 
of x-ray reduction.  
III. METHODS 
 
This study is a prospective, randomized, non-blinded evaluation of the use of 
ultrasound to diagnosis shoulder dislocation in emergency departments. The study 
population will consist of patients aged 18-65 that present to the VCU Emergency 
Department between August 1, 2020 and December 31, 2022 with suspicion of an 
uncomplicated shoulder dislocation. 
 
Procedural Overview/Design: 
1. Assess patient for enrollment. Apply inclusion and exclusion criteria (below). 
2. Discuss Informed consent with patient. If patient consents, proceed to step 3. 
3. Randomize patient with premade numbered envelopes stating standard of care or 
ultrasound protocol (description below).  
A. Diagnosis of dislocation 
1. Standard of Care (control): Order shoulder x-rays as felt necessary for    
standard of care of diagnosis of shoulder dislocation and reduction 
(portable XR versus done in radiology) 

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            2. Ultrasound (experiment): No x-rays ordered. Initial evaluation with     
ultrasound; may also evaluate nearby areas for concern of fracture. Order x- 
rays after ultrasound as seen fit for other injuries of diagnostic uncertainty. 
B. Shoulder reduction: Per standard of care 
C. Confirmation of Reduction 
a. Standard of Care (control): Order shoulder x-rays as felt necessary for 
standard of care of reduction confirmation. 
b. Ultrasound (experiment): Use ultrasound for reduction confirmation. 
No x-rays ordered unless ultrasound did not adequately confirm 
D. Post-reduction care (sling, follow-up, etc.): Per standard of care 
 
 
Control Group 
Experimental Group 
Diagnosis of Dislocation 
Standard of Care (x-ray) 
Ultrasound 
Shoulder Reduction 
Per Standard of Care 
Per Standard of Care 
Confirmation of Reduction 
Standard of Care (x-ray) 
Ultrasound 
 
 
 
B.    Study Population: 
 
Inclusion Criteria: 
1. Patients who are 18 years of age or older; and 
2. Present to the VCU Emergency Department between August 1, 2020 and 
December 31, 2022; and  
3. Have clinical signs of uncomplicated shoulder dislocation; and 
4. Agree to participation in the study; and 
5. Provides a written consent to be included in the study. 
 
Exclusion criteria: 
1. Patients who have a level 1 or 2 trauma activation, and/or;  
2. Patients who are pregnant, incarcerated, or unable to consent, and/or; 
3. Patients who have a past medical history of shoulder replacement in 
dislocated shoulder; and/or 
4. Provider Discretion 
 
E. Assessment of Resources 
 
1. Has sufficient access to the study population: 
Emergency Medicine attending and resident physicians will perform the study. They will 
already be in the Emergency Department and therefore will be notified of a patient meeting 
inclusion criteria and immediately be able to complete study following consenting process.  
2. Has sufficient time to conduct and complete the study: 

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This will be a long-term project in the emergency department. Not all ED physicians will be 
participating in this study. The resident physicians and a select group of attending 
physicians will receive a curriculum and conduct the study.  
3. Has adequate qualified staff members to conduct the study: 
All members of the protocol are CITI trained, and will be trained in the data abstraction 
process once they have been approved by the IRB to work on the protocol. The resident, as 
a physician, is qualified to read and interpret medical records, and to accurately abstract 
data and guide students to abstract data from those charts relevant to the study. Any 
residents or medical students interacting with patients will be trained by the PI in the 
appropriate procedures for consenting a patient. 
4. Facility is adequate to conduct the study: 
The facility is adequate to conduct both the prospective data collection component 
as well as the retrospective chart review. The requirements are technological, including 
the point-of-care ultrasound machine, probes, and CCAG owned computers for data 
abstraction and analysis.  
5. Staff has been adequately trained on the protocol and their specific research related duties: 
The co-investigators will be trained on the objectives of the protocol, as well as where in 
the chart to locate the variables to be abstracted for the study prior to formally collecting 
data for the study. 
  
D.   Study Procedures 
• Image acquisition: Shoulder Dislocation 
o Usually curvilinear probe (footprint and depth) 
o Posterior view: Set probe just inferior to scapular spine 
o Follow the scapula LATERALLY; Look for the humeral head 
▪ If NOT Dislocated, the humeral head should be at same depth as 
scapula/glenoid 
▪ ANTERIOR dislocation will appear with head displaced away from 
probe relative to glenoid on the screen (in the anterior direction) 
▪ POSTERIOR dislocation with appear with head towards probe relative 
to glenoid on the screen (in the posterior direction) 
 
Anterior Shoulder Dislocation 
 
 
 
 
 
 

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Same shoulder status-post reduction. Note head now aligned with scapula/glenoid 
 
 
IV. DATA COLLECTION 
 
Patient list and partial data will be sourced from the electronic medical record. Data 
abstraction will be completed in EPIC and billing. 
 
Demographics 
Age 
Gender 
Weight 
Race 
Insurance Status 
 
Past Medical History 
Prior shoulder dislocations 
 
Study Procedure Data 
Group assignment (control or experimental) 
Experience of person performing ultrasound if in experiment group 
Minimal: Minimal prior experience, sufficient training completed 
Moderate: Prior shoulder ultrasound experience 
Expert: Fellowship trained, or significant prior exposure 
Type of sedation/block/analgesic given 
Intra-articular? Nerve block? Procedural sedation? 
Technique of shoulder reduction performed 
Number of x-rays ordered 
If ultrasound group, what x-ray was ordered and why 
Portable? 
Findings 
Type of dislocation (anterior versus posterior) 

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Fractures identified 
Missed diagnoses  
 
Timeline in ED 
ED LOS 
LOS after being roomed 
Time to discharge 
Time the resident physician spent in room  
Time to perform ultrasound 
Diagnosis of dislocation/initial evaluation 
Confirmation of reduction 
 
Patient satisfaction survey 
 
 
1 
(Extremely 
Dissatisfied) 
2 
(Dissatisfied) 
3 
(indifferent) 
4 
(Satisfied) 
5 
(Extremely 
Satisfied) 
Were you satisfied with the overall 
care you received today? 
 
 
 
 
 
Did you comfortable with your wait 
time while in the Emergency 
Department? 
 
 
 
 
 
Do you feel you got imaging of your 
shoulder in a timely fashion? 
 
 
 
 
 
Do you feel your physician discussed 
your diagnosis appropriately? 
 
 
 
 
 
Do you feel your physician updated 
you often enough? 
 
 
 
 
 
Do you feel that your physician 
explain all procedures in a way that 
was clear and you could 
understand? 
 
 
 
 
 
 
 
Cost Analysis 
 Not necessary as patient’s ultrasound exam will not be billed.  
 
Issues/misdiagnosis 
Any concerns by patients or participants will be addressed by PI as soon as possible. We do 
not anticipate any issues or missed diagnoses.  
 
V. 
DATA ANALYSIS 
 

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A. Sample Size Considerations 
1. This study will be a multicenter study. Due to the infrequent nature of this 
injury, the data collection phase will take place over several years. 
 
B. Statistical Methodology 
Descriptive statistics will be used to evaluate demographic variables. Categorical variables 
will be reported as n (%) and will be analyzed by chi-square or Fisher’s exact test as 
appropriate. Normally distributed continuous variables will be reported as mean and 
standard deviation and will be analyzed by student’s t-test. Non-normally distributed 
continuous variables will be reported as medians and interquartile range and analyzed 
using Mann-Whitney U test. The primary outcome of difference in average length of stay in 
the ED will be analyzed by paired students T-test. Secondary outcomes will be evaluated by 
paired student t-tests as well. Statistical analysis will be performed using SPSS® Software 
(version 24; 2016) and the level of significance set at p value less than 0.05.  
 
VI. DATA AND SAFETY MONITORING PLAN (if applicable) 
 
This data will be stored behind the VCU firewall and on Redcap and if any transfer of data is 
necessary this will be done on RedCap. Once the data is collected the data will be de-
identified for analysis. 
VII. STUDY LIMITATIONS 
 
Potential selection bias based on the inclusion/exclusion criteria may reduce external 
validation. Theoretical user error could cause misinterpretation in ultrasound findings; this 
is a low risk, and has built in protection. It may be a challenge to get IRB approval across all 
institutions Missing data or incomplete data for specific fields may also present error.  
 
 
VIII. ETHICAL CONSIDERATIONS 
    A.  Informed Consent (Applies to studies using human subjects) 
Only patients who are able to provide written consent will be included. Those patients who 
are able to provide consent will be provided a brief explanation of the study and given the 
opportunity to ask questions, and ultimately provide or decline written consent. 
Ultrasound is a common modality used to evaluate minor musculo-skeletal issues in 
routine patient care in the emergency department and poses no harm to patient as it uses 
no ionizing radiation. The conduct of this research will present no more than minimal risk 
to the patient.   
 
B. Risks and Side Effects (Applies to studies using human subjects) 
Ultrasound evaluation poses minimal risks and side effects to patients. If the 
ultrasound evaluation is insufficient it could interfere with patient care activities 
increasing the risk for morbidity and mortality as a result of delayed treatment as 
above.   

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C. Benefits to Subjects (Applies to studies using human subjects) 
Potential benefits to patients in the experimental arm of this study include 
decreased length of stay and decreased exposure to ionizing radiation. 
  
D. Costs to Subject  
The patient will be responsible for the cost of their care, whether it is an ultrasound 
or an x-ray. 
 
E. Compensation to Subject  
There will be no compensation for subjects. 
 
F.  Provisions for vulnerable subjects  
There will be no vulnerable subjects in this study as per inclusion criteria. 
 
G. Subject Privacy and Data Confidentiality  
  
C. Privacy of Participants: 
Privacy of participants will be protected by the following: Patient information will be 
stored in secure software and on VCU computers and mobile devices.   
 
D. Confidentiality of Data 
As described above, all data will remain on-site at VCU, maintained in a secure environment 
and password protected. Data will be summarized and presented in aggregate form for 
reporting purposes. Dissemination will include a report to VCU. A manuscript will be 
drafted for peer-review publication.  
 
3. Plan for Record Retention and disposal 
Records will be stored for 3 years following completion of the study and then destroyed. 
 
              4. Limits to Confidentiality 
 
 
       There is no anticipated limit to confidentiality. 
 
IX. PLANS FOR DISSEMINATION OF FINDINGS 
Findings will be disseminated via a peer-reviewed publication and through presentations. 
Finding will be presented in aggregate form, without comparison or specific identification 
of institutions within the VCU Hospital Network. Specifically, the results will be presented 
to the local stakeholders and at least one national conference. Staff members working on 
this project have a strong track record of publishing manuscripts in peer-reviewed journals 
and presenting at statewide and national conferences. In addition, a comprehensive report 
of the study findings will be created and made available to VCU stakeholders. 
 
X.  REFERENCES 
 

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 Janitzky AA, Akyol C, Kesapli M, Gungor F, Imak A, Hakbilir O. Anterior Shoulder 
Dislocations in Busy Emergency Departments: The External Rotation Without Sedation and 
Analgesia (ERWOSA) Method May Be the First Choice for Reduction. Medicine (Baltimore). 
2015;94(47):e1852. doi:10.1097/MD.0000000000001852 
 
2 Zacchilli MA, Owens BD. Epidemiology of shoulder dislocations presenting to emergency 
departments in the United States. J Bone Joint Surg Am 2010; 92:542. 
 
3 Kendall JL, Hoffenberg SR, Smith RS. History of emergency and critical care ultrasound: 
the evolution of a new imaging paradigm. Crit Care Med. 2007;35(5):S126eS130. 
 
4 Blakeley CJ, Spencer O, Newman-Saunders T, et al. A novel use of portable ultrasound in 
the management of shoulder dislocation. Emerg Med J. 2009;26(9):662-3. 
 
5 Halberg MJ, Sweeney TW, Owens WB. Bedside ultrasound for verification of shoulder 
reduction. Am J Emerg Med. 2009;27(1):134.e5-6.  
 
6 Mackenzie DC, Liebmann O. Point-of-care ultrasound facilitates diagnosing a posterior 
shoulder dislocation. J Emerg Med. 2013;44(5):976-8.  
 
7 Beck S, Chilstrom M. Point-of-care ultrasound diagnosis and treatment of posterior 
shoulder dislocation. Am J Emerg Med. 2013;31(2):449.e3-5.  
 
8 Gottlieb M, Russell F. Diagnostic Accuracy of Ultrasound for Identifying Shoulder 
Dislocations and Reductions: A Systematic Review of the Literature. West J Emerg Med. 
2017;18(5):937–942. doi:10.5811/westjem.2017.5.34432 
 
9 Abbasi S, Molaie H, Hafezimoghadam P, et al. Diagnostic accuracy of ultrasonographic 
examination in the management of shoulder dislocation in the emergency department. Ann 
Emerg Med. 2013;62(2):170-5.  
 
10 Lahham S, Becker B, Chiem A, et al. Pilot study to determine accuracy of posterior 
approach ultrasound for shoulder dislocation by novice sonographers. West J Emerg Med. 
2016;17(3):377-82.  
 
11 Shuster M, Abu-Laban RB, Boyd J. Prereduction radiographs in clinically evident anterior 
shoulder dislocation. Am J Emerg Med. 1999;17(7):653-8. 
 
 
XI. APPENDICES  
 
A. Instruments, rating scales, consent forms, etc. 
 
 
 

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