Plain English Summary
Background and study aims
The purpose of this study is to determine whether ultrasound improves diagnostic accuracy when used with physical examination for confirmation of shoulder dislocation and for confirmation of shoulder reduction. The current practice involves physical examination and X-rays (that rely on harmful ionising radiation) to evaluate for any dislocations and/or fractures of the shoulder and upper arm. X-rays will be used as the gold standard investigation for this study.
Who can participate?
All adult patients presenting to the Emergency Department of Mater Dei Hospital in Malta, with acute trauma to the shoulder will be eligible to take part in the study.
What does the study involve?
A number of emergency doctors will be trained to do an ultrasound investigation to check specifically for shoulder dislocation and an upper arm fracture. Patients who fit the inclusion criteria for this study will be asked for consent to take part in this study. They will also be randomised to one of two groups. The control group is the standard physical examination alone and the experimental group which involves adding ultrasound to the physical examination. All patients will have X-rays done as per standard protocol irrespective of which group they are randomised to. Those patients who have a shoulder dislocation will need reduction as per the standard procedure. These patients will have a second examination following reduction. This examination will be either a physical exam or ultrasound exam, depending on which group patients were randomised to initially. All Emergency doctors taking part in this study are advanced trainees or specialists in emergency medicine with training in Level 1 ultrasound as a minimum. All X-rays will be reported by board-certified radiologists.
What are the possible benefits and risks of participating?
No painful, time consuming or irradiating interventions will be added on to participants. The participants themselves may benefit from the conclusions of the study. Benefits for future treatments may include a decreased radiation dose and exposure, a shorter time in the ED, confirmation of shoulder reduction at bedside (thus avoiding unnecessary re-sedation) and fewer costs.
Where is the study run from?
Mater Dei Hospital Emergency Department, Malta
When is the study starting and how long is it expected to run for?
October 2019 to March 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mark Anthony Attard Biancardi
markbiancardi11@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Anthony Attard Biancardi
ORCID ID
Contact details
Mater Dei Hospital
Triq Dun Karm
L-Imsida
MSD2090
Malta
+356 79229173
mark-anthony.attard@gov.mt
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
FRECMDS_1819_036
Study information
Scientific title
In adult patients (age >16yrs) presenting to the ED with acute traumatic shoulder pain, can PoCUS improve diagnostic accuracy for shoulder dislocation with or without proximal humeral fractures and shoulder reduction when combined to physical examination as opposed to physical examination alone?
Acronym
Study hypothesis
H0: The null hypothesis for this study will be that there is no difference in diagnostic accuracy between physical examination with PoCUS and physical examination alone using X-rays as the gold standard.
H1: The unidirectional experimental hypothesis, however, will be that diagnostic accuracy will be significantly higher when using point of care ultrasound with physical examination.
Ethics approval
1. Approved 27/03/2019, Faculty Research Ethics Committee of Medicine and Surgery University of Malta (Faculty of Health Sciences, Mater Dei Hospital, Msida, Malta, MSD 2080; +356 23401830; healthsciences@um.edu.mt), ref: FRECMDS_1819_036
2. Approved 07/09/2019, Research Ethics Sub-Committee School of Health and Social Care Teesside University (Teesside University, Middlesbrough, Tees Valley, TS1 3BX, UK; +44 (0)1642 21812; SOHSC-Ethics@tees.ac.uk), ref: 281/18
Study design
Single-centre quantitative open parallel randomised control study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Shoulder dislocations with or without proximal humeral fractures
Intervention
Consecutive patients presenting to Mater Dei Hospital ED, with acute traumatic shoulder pain will be eligible to take part in the study. Eligible patients will be accompanied to a predefined room and adequate analgesia will be administered. Consent will be obtained from the patient.
Patients will be randomised to either the control (physical examination only) or experimental group (physical examination and POCUS), by opening a sealed envelope. These envelopes will be prepared before the start of the study and will contain computer generated random allocations.
The investigator will then proceed to perform either the clinical examination or the clinical examination with PoCUS. Patients will then proceed to X-rays (gold standard) as per usual protocol to confirm diagnosis.
After completion of X-rays, patients will either proceed to have a shoulder dislocation reduction or other treatment if reduction is deemed inappropriate or not necessary by the investigator. After reduction, another examination will be conducted (depending on which limb patient was randomised) to ascertain successful reduction. Investigators will record findings on a data collection sheet before any X-rays to minimise review bias. All X-rays will be reported by the attending radiologists who are blinded to the investigator’s results to avoid diagnostic review bias.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Success rate of clinical examination or the clinical examination with PoCUS at detecting the presence or absence of shoulder dislocation with or without proximal humeral fracture and the presence or absence of successful shoulder reduction
Secondary outcome measures
None
Overall trial start date
01/01/2019
Overall trial end date
31/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Over 16 years old
2. Acute shoulder pain and decreased range of motion post-trauma
3. Patient able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Total final enrolment
1206
Participant exclusion criteria
1. Chronic shoulder pain
2. Poly-trauma patients needing emergency surgery like laparotomy
3. Patients referred with a confirmed diagnosis of shoulder dislocations on X-ray
Recruitment start date
01/10/2019
Recruitment end date
31/03/2020
Locations
Countries of recruitment
Malta
Trial participating centre
Mater Dei Hospital Emergency Department
Triq Dun Karm
Msida
MSD2090
Malta
Sponsor information
Organisation
Faculty of Medicine and Surgery University of Malta Malta Medical School
Sponsor details
Block A
Level 0
Room 364
Mater Dei Hospital
Msida
MSD 2090
Malta
+356 23401891
research-ethics.ms@um.edu.mt
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in a medical journal once analysis is completed.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality
Intention to publish date
01/09/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list