Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000286741
Ethics application status
Approved
Date submitted
17/08/2021
Date registered
15/02/2022
Date last updated
15/02/2022
Date data sharing statement initially provided
15/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of the efficacy of three methods of relocating the dislocated shoulder: Chair, FARES (FAst, REliable and Safe), and Cunningham's
Scientific title
A comparison of the efficacy of FARES, Chair and Cunningham’s methods of shoulder reduction in the non-sedated patients for anterior shoulder dislocation. A randomised control trial.
Secondary ID [1] 305001 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Dislocated Shoulder 323161 0
Condition category
Condition code
Emergency medicine 320746 320746 0 0
Other emergency care
Musculoskeletal 321060 321060 0 0
Other muscular and skeletal disorders
Injuries and Accidents 321061 321061 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted in a metropolitan emergency department in Sydney, NSW, Australia. The study will compare three methods of shoulder relocation that utilise different patient positioning and biomechanics to relocate the shoulder. An abduction and an adduction method will be compared with the chair method that utilises traction. The intervention with be performed by Emergency Department Nurse Practitioners, Physiotherapists and Medical Officers in the Fast track zone of the emergency department. Prior to commencement of the study each participating clinician will have face to face training to ensure the each method is performed according to the following descriptions.

Chair method (Traction)
The Chair Method is a traction technique that uses the back of a chair as a fulcrum whilst the clinician applies traction to the patient's arm. The patient sits sideways on the chair with their arm hanging over the backrest with a rolled towel placed under the axilla for padding. The clinician assumes a crouched position whilst holding the patient’s elbow and hand. Traction is gradually applied until reduction occurs (Guler, et al, 2015). This method was first described by Hippocrates in the 4th century BC (Mattick, 2000). Since then, the chair method has been described several times in the literature.

The Cunningham Method (Adduction)
The patient is seated with their elbow flexed and their hand resting on the clinician’s shoulder. The patient is encouraged to sit upright with their shoulders shrugged superiorly and posteriorly to retrovert the scapula and overcome the static obstruction of the glenoid rim. The clinician massages the bicep muscle to overcome the dynamic obstruction of the spasming musculature (Cunningham 2005).

Fares Method (Abduction)
With the patient lying supine, the extended arm is abducted to 90 degrees whilst performing gentle vertical oscillating movements. At 90 degrees the arm is externally rotated. Reduction usually occurs at approximately 120 degrees of abduction (Maity 2012).

The clinicians will have 0-5 minutes to attempt each methods and then move on to subsequent methods. The order of methods used to reduce the shoulder dislocation will be randomly applied to each patient. Participants may receive one, two or all three methods depending upon success/failure. For example, if Cunningham's (Method one) is unsuccessful, then FARES (method two) is applied. If FARES is unsuccessful, then Chair (method three) is applied.
Intervention code [1] 321395 0
Treatment: Other
Comparator / control treatment
The Chair Method is standard care for this study. Prior to study commencement it was the most utilised method of shoulder reduction within the Fast Track Zone of the Emergency Department.
Control group
Active

Outcomes
Primary outcome [1] 328557 0
The primary aim of this study is to compare three biomechanically different shoulder reduction methods to determine which method is superior. Superiority being defined as success on first attempt at reduction of the shoulder. Success or failure of shoulder reduction will be assessed by confirmation with x-ray.
Timepoint [1] 328557 0
Immediately post-shoulder reduction
Secondary outcome [1] 399413 0
Number of clinicians required for reduction assessed by accessing patient medical record
Timepoint [1] 399413 0
At the time of intervention
Secondary outcome [2] 399415 0
Duration from triage to reduction assessed by accessing patient medical record
Timepoint [2] 399415 0
At the time of intervention
Secondary outcome [3] 399417 0
Number of iatrogenic injuries resulting from shoulder reduction assessed as a composite of shoulder x-ray and clinical examination
Timepoint [3] 399417 0
Immediately post shoulder reduction
Secondary outcome [4] 399418 0
Requirement for analgesia assessed by accessing patient medication chart
Timepoint [4] 399418 0
Assessed from time of emergency department presentation until the time of successful shoulder reduction.

Eligibility
Key inclusion criteria
Anterior shoulder dislocations presenting to Nepean Emergency Department
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• delay in shoulder relocation (>24 hours)
• fracture dislocations (excluding Hill Sachs and Bankart fractures)
• recurrent dislocations of the same joint (>3 dislocations in 12 months)
• posterior dislocation
• age less than 16 years
• age greater than 75 years
• trauma with multiple injuries

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The method of randomisation will be by random number sequence. The order of method used to reduce the shoulder dislocation will be randomly applied to each patient. For example, study patient one is randomised to Cunninghams, Fares and then Chair in that order. The clinician has one attempt at reduction with each method. If the first method (Cunninghams) fails then the second method (Fares) is attempted. If the second method fails, then the third method (Chair) is attempted
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data collected from the study will be entered into SPSS 25 (IBM Corp, 2013) for quantitative data analysis. Demographic information will be collated. Data will be analysed using descriptive statistics with medians or means with standard deviations and 95% confidence intervals.
We are planning a study with 75 experimental subjects in each of the 3 interventions, Chair, Cunningham's and FARES (Chair being considered the control intervention for the purpose of data analysis) . Prior data indicate that the failure rate among controls is 0.5 (Chair method). We will be able to detect true failure rates of .279 or .721 in exposed subjects with a power of 0.8 and an alpha of 0.05. Analysis of categorical variables will be completed with Pearson Chi-squared or Fisher Exact Test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/06/2021
Date of last participant enrolment
Anticipated
12/06/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20253 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 34992 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 309382 0
Hospital
Name [1] 309382 0
Nepean Hospital
Country [1] 309382 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Nepean Hospital
Derby st Kingswood, NSW
2749
Country
Australia
Secondary sponsor category [1] 310426 0
None
Name [1] 310426 0
NONE
Address [1] 310426 0
Country [1] 310426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309197 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 309197 0
Ethics committee country [1] 309197 0
Australia
Date submitted for ethics approval [1] 309197 0
06/04/2021
Approval date [1] 309197 0
25/04/2021
Ethics approval number [1] 309197 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113314 0
Mr David Ralphs
Address 113314 0
Nepean Hospital Emergency Department
Derby st Kingswood, NSW
2749
Country 113314 0
Australia
Phone 113314 0
+61 0413709395
Fax 113314 0
Email 113314 0
[email protected]
Contact person for public queries
Name 113315 0
David Ralphs
Address 113315 0
Nepean Hospital Emergency Department
Derby st Kingswood, NSW
2749
Country 113315 0
Australia
Phone 113315 0
+61 0413709395
Fax 113315 0
Email 113315 0
[email protected]
Contact person for scientific queries
Name 113316 0
David Ralphs
Address 113316 0
Nepean Hospital Emergency Department
Derby st Kingswood, NSW
2749
Country 113316 0
Australia
Phone 113316 0
+61 0413709395
Fax 113316 0
Email 113316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.