Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000612718p
Ethics application status
Submitted, not yet approved
Date submitted
1/04/2022
Date registered
26/04/2022
Date last updated
26/04/2022
Date data sharing statement initially provided
26/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an ergonomics educational program on work related musculoskeletal disorders: A cluster randomised control trial.
Scientific title
Effect of an ergonomics educational program on work related musculoskeletal disorders: A cluster randomised control trial.
Secondary ID [1] 306368 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work related musculoskeletal disease 325171 0
Condition category
Condition code
Musculoskeletal 322577 322577 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will utilise ergonomic education. RESPite is an online targeted ergonomics educational intervention for sonographers. It is expected it will require 30 mins to complete. This education was designed by sonographers, ergonomists and physiotherapists. There are six modules. The first module is information about work related musculoskeletal disease (WMSD) in sonographers and contains a short quiz. Module two is information on risk factors for WMSD in sonographers. Modules three, four and five contain short videos with recommended strategies for sonographers to reduce reach, reduce probe pressure and grip force and to reduce neck and trunk rotation. The final module is a conclusion with reinforcement of the strategies. The intervention can be accessed online and as many times as the participant wants to. it will be available for three months after completion of the trial. A copy of the Australasian Sonographers Association (ASA) and The Australasian Society for Ultrasound in Medicine (ASUM) joint guidelines for reducing injuries to all ultrasound users will also be delivered by email as part of the intervention. Participants are encouraged to implement the tips given in the training into their everyday practice as a sonographer. Intervention adherence will be assessed by a research completion survey at the completion of the trial.
Intervention code [1] 322796 0
Prevention
Comparator / control treatment
Control group will be emailed the ASA and ASUM joint guidelines for reducing injuries to all ultrasound users and asked to read them and consider implementing ergonomic scanning practices. Time required to read the guidelines is expected to be 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 330378 0
Difference in musculoskeletal pain of the shoulder as assessed by Shoulder Pain and disability Index (SPADI)
Timepoint [1] 330378 0
Baseline - concurrent with the assignment to intervention or control group and access to education.
8 weeks after being assigned and given access to the control or intervention (for assessing short term changes)
24 weeks after being assigned and given access to the control or intervention (for assessing long term changes)

No primary time point.
Primary outcome [2] 331007 0
Difference in musculoskeletal pain of the neck as assessed by Question 1 of the Neck Disability Index (NDI)
Timepoint [2] 331007 0
Baseline - concurrent with the assignment to intervention or control group and access to education.
8 weeks after being assigned and given access to the control or intervention (for assessing short term changes)
24 weeks after being assigned and given access to the control or intervention (for assessing long term changes)

No primary timepoint.
Primary outcome [3] 331008 0
Difference in musculoskeletal disability of the shoulder as assessed by Shoulder Pain and disability Index (SPADI)
Timepoint [3] 331008 0
Baseline - concurrent with the assignment to intervention or control group and access to education.
8 weeks after being assigned and given access to the control or intervention (for assessing short term changes)
24 weeks after being assigned and given access to the control or intervention (for assessing long term changes)
No primary timepoint
Secondary outcome [1] 406011 0
Difference in workability pre to post-intervention measured by the Work Ability Score (WAS).

Timepoint [1] 406011 0
Baseline - concurrent with the assignment to intervention or control group and access to education.
24 weeks after being assigned and given access to the control or intervention
Secondary outcome [2] 408467 0
Evaluation of the usefulness of the intervention as assessed by a Likert 5 point scale (very useful to completely useless)
Timepoint [2] 408467 0
24 weeks after being assigned and given access to the control or intervention.
Secondary outcome [3] 408468 0
Primary Outcome: Difference in musculoskeletal disability of the neck as assessed by Question 1 of the Neck Disability Index (NDI).
Timepoint [3] 408468 0
Baseline - concurrent with the assignment to intervention or control group and access to education.
8 weeks after being assigned and given access to the control or intervention (for assessing short term changes)
24 weeks after being assigned and given access to the control or intervention (for assessing long term changes)
No primary timepoint.
Secondary outcome [4] 408473 0
Degree of implementation of strategies (checkbox answers and optional comments).
Timepoint [4] 408473 0
24 weeks after being assigned and given access to the control or intervention.

Eligibility
Key inclusion criteria
Sonographers or trainee songraphers employed by a NSW Local Health District and performing ultrasound examinations
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes by computer randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No - cluster randomised by local health district. Assignment of a cluster to either control or intervention will be simple randomisation (coin toss)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomisation by Local Health District
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed to assess normality using the Kolmogorov-Smirnov test. Depending on distribution of the data, parametric and/or non parametric tests will be used to compare the difference in outcome measures between the two groups. The tests will be a paired t-test for normally distributed data and a Mann Whitney test otherwise.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
16/05/2022
Actual
Date of last data collection
Anticipated
21/11/2022
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22105 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 22106 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 22107 0
Belmont Hospital - Belmont
Recruitment hospital [4] 22108 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 22109 0
Cessnock District Hospital - Cessnock
Recruitment hospital [6] 22110 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [7] 22111 0
The Maitland Hospital - Maitland
Recruitment hospital [8] 22112 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [9] 22113 0
Westmead Hospital - Westmead
Recruitment hospital [10] 22114 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [11] 22115 0
Blacktown Hospital - Blacktown
Recruitment hospital [12] 22116 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [13] 22117 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [14] 22118 0
Griffith Base Hospital - Griffith
Recruitment hospital [15] 22119 0
Ballina District Hospital - Ballina
Recruitment hospital [16] 22120 0
Byron District Hospital - Byron Bay
Recruitment hospital [17] 22121 0
Grafton Base Hospital - Grafton
Recruitment hospital [18] 22122 0
Casino and District Memorial Hospital - Casino
Recruitment hospital [19] 22123 0
Lismore Base Hospital - Lismore
Recruitment hospital [20] 22124 0
Maclean District Hospital - Maclean
Recruitment hospital [21] 22125 0
Murwillumbah District Hospital - Murwillumbah
Recruitment hospital [22] 22126 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [23] 22127 0
Batemans Bay Hospital - Batemans Bay
Recruitment hospital [24] 22128 0
Bega District Hospital - Bega
Recruitment hospital [25] 22130 0
Cooma Hospital & Health Service - Cooma
Recruitment hospital [26] 22131 0
Goulburn Base Hospital - Goulburn
Recruitment hospital [27] 22132 0
Yass District Hospital - Yass
Recruitment hospital [28] 22133 0
Queanbeyan District Hospital - Queanbeyan
Recruitment hospital [29] 22134 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [30] 22135 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [31] 22136 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 37229 0
2050 - Camperdown
Recruitment postcode(s) [2] 37230 0
2305 - New Lambton
Recruitment postcode(s) [3] 37231 0
2280 - Belmont
Recruitment postcode(s) [4] 37232 0
2298 - Waratah
Recruitment postcode(s) [5] 37233 0
2325 - Cessnock
Recruitment postcode(s) [6] 37234 0
2430 - Taree
Recruitment postcode(s) [7] 37235 0
2320 - Maitland
Recruitment postcode(s) [8] 37236 0
2144 - Auburn
Recruitment postcode(s) [9] 37237 0
2145 - Westmead
Recruitment postcode(s) [10] 37238 0
2148 - Blacktown
Recruitment postcode(s) [11] 37239 0
2770 - Mount Druitt
Recruitment postcode(s) [12] 37240 0
2650 - Wagga Wagga
Recruitment postcode(s) [13] 37241 0
2680 - Griffith
Recruitment postcode(s) [14] 37242 0
2478 - Ballina
Recruitment postcode(s) [15] 37243 0
2481 - Byron Bay
Recruitment postcode(s) [16] 37244 0
2460 - Grafton
Recruitment postcode(s) [17] 37245 0
2470 - Casino
Recruitment postcode(s) [18] 37246 0
2480 - Lismore
Recruitment postcode(s) [19] 37247 0
2463 - Maclean
Recruitment postcode(s) [20] 37248 0
2484 - Murwillumbah
Recruitment postcode(s) [21] 37249 0
2485 - Tweed Heads
Recruitment postcode(s) [22] 37250 0
2536 - Batemans Bay
Recruitment postcode(s) [23] 37251 0
2550 - Bega
Recruitment postcode(s) [24] 37253 0
2630 - Cooma
Recruitment postcode(s) [25] 37254 0
2580 - Goulburn
Recruitment postcode(s) [26] 37255 0
2582 - Yass
Recruitment postcode(s) [27] 37256 0
2620 - Queanbeyan
Recruitment postcode(s) [28] 37257 0
2200 - Bankstown
Recruitment postcode(s) [29] 37258 0
2560 - Campbelltown
Recruitment postcode(s) [30] 37259 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 310722 0
University
Name [1] 310722 0
The University of Sydney
Country [1] 310722 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Camperdown
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 311944 0
None
Name [1] 311944 0
Address [1] 311944 0
Country [1] 311944 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310299 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 310299 0
PO Box 4061, Dubbo NSW 2830.
Ethics committee country [1] 310299 0
Australia
Date submitted for ethics approval [1] 310299 0
01/04/2022
Approval date [1] 310299 0
Ethics approval number [1] 310299 0

Summary
Brief summary
The aim of this study is to assess the effect of an ergonomics intervention on sonographer work-related musculoskeletal disease. The study will be a randomised cluster control trial. The intervention used will be RESPite, which is an online multimedia ergonomics educational program with simple techniques that sonographers can integrate into their working day. It is hypothesised that RESpite will reduce the musculoskeletal pain and dysfunction of the shoulder and neck in sonographers compared to standard ergonomic guidelines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117170 0
A/Prof Jillian Clarke
Address 117170 0
The University of Sydney
Camperdown
NSW 2006
Australia
Country 117170 0
Australia
Phone 117170 0
+61 02 9351 9516
Fax 117170 0
Email 117170 0
[email protected]
Contact person for public queries
Name 117171 0
Ms Kristie Sweeney
Address 117171 0
Medical Imaging
Bathurst Health Service
Howick St
Bathurst
NSW 2795
Country 117171 0
Australia
Phone 117171 0
+61 263305224
Fax 117171 0
Email 117171 0
[email protected]
Contact person for scientific queries
Name 117172 0
Ms Kristie Sweeney
Address 117172 0
Medical Imaging
Bathurst Health Service
Howick St
Bathurst
NSW 2795
Country 117172 0
Australia
Phone 117172 0
+61 263305224
Fax 117172 0
Email 117172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data, after deidentification, of published results.
When will data be available (start and end dates)?
After publication, for fifteen years
Available to whom?
Case by case basis as determined by primary sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approval by Jillian Clarke [email protected]


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.