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Trial registered on ANZCTR


Registration number
ACTRN12623001285640
Ethics application status
Approved
Date submitted
26/10/2023
Date registered
11/12/2023
Date last updated
11/12/2023
Date data sharing statement initially provided
11/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound measurement of stable and unstable shoulders
Scientific title
Differences in humeral head position and translation between stable and unstable shoulders: an ultrasound study
Secondary ID [1] 310677 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder instability 331590 0
Condition category
Condition code
Musculoskeletal 328323 328323 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional observation trial comparing the ultrasound measurement of humeral head position / translation of unstable and stable shoulders.

The participant will be standing with the shoulder exposed. The ultrasound transucer will be placed on the shoulder while participants hold 2kg in the hand, lift their arm up 60 degrees to the side, push out to the side against a 2kg cable weight, and rotate their arm to the side. They will be required to raise and lower their arm between repeat measures to briefly assess assessor reliability.

This process will take up to 20 minutes.

Ultrasound measures will be completed by a physiotherapist (DV).

No exercise/warm-up will be required prior or during the ultrasound assessment.
Intervention code [1] 327259 0
Diagnosis / Prognosis
Comparator / control treatment
Age and gender matched controls with asymptomatic shoulders for comparison to unstable shoulders
Control group
Active

Outcomes
Primary outcome [1] 336171 0
Acromiohumeral distance
Timepoint [1] 336171 0
During once off ultrasound procedure
Secondary outcome [1] 427205 0
Glenohumeral distance
Timepoint [1] 427205 0
During once off ultrasound procedure
Secondary outcome [2] 427206 0
resisted external rotation strength
Timepoint [2] 427206 0
During once off ultrasound procedure
Secondary outcome [3] 427207 0
Scapular upward rotation angle
Timepoint [3] 427207 0
During once off ultrasound procedure

Eligibility
Key inclusion criteria
UNSTABLE SHOULDERS:
- Symptomatic subluxation or dislocation inferiorly +/- anterior or posterior direction
- Positive sulcus test
- Improvement in range of motion in abduction by >20 degrees, OR improvement of pain or guarding in abduction, OR improvement in strength on an isometric test

STABLE SHOULDERS
- Symptom-free shoulder
- Negative sulcus test
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
UNSTABLE / STABLE SHOULDERS:
- History of significant trauma to the shoulder
- History of surgery on the affected shoulder
- Unable to understand or follow instructions in English
- Known neurological pathology creating motor deficit
- Known upper or lower motor neurone disease
- Known connective tissue disorder (Ehlers Danlos / Marfan syndrome)
- Presence of cervical radiculopathy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/12/2022
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
30
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314898 0
University
Name [1] 314898 0
La Trobe University
Country [1] 314898 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road and, Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 316901 0
None
Name [1] 316901 0
Address [1] 316901 0
Country [1] 316901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313891 0
La Trobe Human Research Ethics Committee
Ethics committee address [1] 313891 0
La Trobe University, Plenty Road and, Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 313891 0
Australia
Date submitted for ethics approval [1] 313891 0
24/03/2022
Approval date [1] 313891 0
19/09/2022
Ethics approval number [1] 313891 0
HEC22126

Summary
Brief summary
This is the first component of a masters project that is investigating humeral head position and translation in unstable shoulders. In this observational study, we aim to measure the differences in humeral head position and/or translation between unstable and stable shoulders. We hypothesise that there will be detectable differences between stable and unstable shoulders as measured by ultrasound. This may then inform treatment strategies that aim to address the pathological humeral head position / translation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129694 0
Mr Daniel Verdon
Address 129694 0
Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181
Country 129694 0
Australia
Phone 129694 0
+61 3 9228 0911
Fax 129694 0
+61 3 9228 0913
Email 129694 0
[email protected]
Contact person for public queries
Name 129695 0
Daniel Verdon
Address 129695 0
Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181
Country 129695 0
Australia
Phone 129695 0
+61 3 9228 0911
Fax 129695 0
+61 3 9228 0913
Email 129695 0
[email protected]
Contact person for scientific queries
Name 129696 0
Daniel Verdon
Address 129696 0
Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181
Country 129696 0
Australia
Phone 129696 0
+61 3 9228 0911
Fax 129696 0
+61 3 9228 0913
Email 129696 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20605Ethical approval    386659-(Uploaded-05-10-2023-13-28-52)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
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