Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000800426
Ethics application status
Approved
Date submitted
7/06/2016
Date registered
20/06/2016
Date last updated
14/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Asymmetry of lumbar multifidus thickness in cricket pace bowlers measured with real-time ultrasound.
Scientific title
Side to side differences in lumbar multifidus thickness and recruitment measured with real-time ultrasound: a comparison study of amateur cricket pace bowlers and a healthy control population.
Secondary ID [1] 287137 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asymmetry of lumbar multifidus muscle thickness and recruitment. 295685 0
Condition category
Condition code
Musculoskeletal 295961 295961 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional observational study using real-time ultrasound to measure lumbar multifidus resting thickness and recruitment in amateur pace bowling cricketers and non-cricketers (the "control"group). Single session measurements to be performed with no follow up required. Approximately 15-20 minutes per session required to perform all measurements. A fourth year undergraduate Bachelor of Physiotherapy (Honours) student is assigned as the principal investigator and performed all measurements.
Intervention code [1] 292400 0
Not applicable
Comparator / control treatment
Healthy age matched control population to amateur cricket pace bowling group. Observational measurements made again.
Demographic details (age, hand dominance, low back pain or injury history, sporting history) were gathered through a survey sheet. Height and weight were measured to calculate BMI for each participant. Ultrasound movies approximately 20 seconds long captured for lumbar multifidus on the left and right sides at rest and in a contracted state (4 movies total). All collection to take approximately 15-20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 295644 0
Statistical difference between cricket pace bowlers and non-cricketers when comparing left and right sides of lumbar multifidus resting thickness. Ultrasound imaging (Venue 40 Model R1.x.x; GE Helathcare, Jiangsu, P.R. China) with a force probe (Gilbertson, M. & Anthony, B., 2011) for between image standardisation used to capture images of the muscle. Image J software will be used to analyse the images.
Timepoint [1] 295644 0
Baseline.
Secondary outcome [1] 316070 0
Statistical difference between cricket pace bowlers and non-cricketers when comparing left and right sides of lumbar multifidus muscle recruitment. Ultrasound imaging (Venue 40 Model R1.x.x; GE Helathcare, Jiangsu, P.R. China) with a force probe (Gilbertson, M. & Anthony, B., 2011) for between image standardisation used to capture images of the muscle. Image J software will be used to analyse the images.
Timepoint [1] 316070 0
Baseline.

Eligibility
Key inclusion criteria
Both groups: aged 12 to 50 years old, male.
Cricket group: pace bowlers or all-rounders who bowl pace who play in Townsville A Grade or Reserve grade divisions of cricket.
Minimum age
12 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Both groups: female, contraindications to real-time ultrasound, recent lumbar injury or surgery, lower back pain in previous 3 months, symptomatic congenital lumbar pathologies, specific spinal stabilisation training for lumbar multifidus in the last 3months
Cricket group: spin bowlers, batsmen and fielders.
Control group: participate in other asymmetrical upper limb sports (eg: golf or tennis).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Previous data from Hides et al (1992) was used in the sample size calculation, who reported medically relevant difference of 2.2 and an estimated standard deviation of 2.5. Alpha was set at 0.05 and Beta was set at 0.2, meaning the power was 0.8. Using a nonogram a required sample of 40 was found to be required.
ImageJ software will be used to measure lumbar multifidus thickness and recruitment from still ultrasound images.
Microsoft Excel spreadsheets will be used for all calculations.
To determine between group differences SPSS Software (IBM SPSS Statistics 23.0) will be used. Parametric (unpaired T test) or non-parametric (Mann-Whitney U) tests will be conducted to determine statistical between group differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2016
Date of last participant enrolment
Anticipated
Actual
11/05/2016
Date of last data collection
Anticipated
Actual
11/05/2016
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291695 0
University
Name [1] 291695 0
James Cook University
Country [1] 291695 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive, Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 290371 0
None
Name [1] 290371 0
Address [1] 290371 0
Country [1] 290371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293220 0
James Cook University Human Ethics
Ethics committee address [1] 293220 0
Ethics committee country [1] 293220 0
Australia
Date submitted for ethics approval [1] 293220 0
17/08/2015
Approval date [1] 293220 0
07/10/2015
Ethics approval number [1] 293220 0
H6354

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

Contacts
Principal investigator
Name 58966 0
Mr Matthew Toumazou
Address 58966 0
Matthew Toumazou James Cook University 1 James Cook Drive, Townsville QLD 4811. Room 043 017.
Country 58966 0
Australia
Phone 58966 0
+61 7 4781 6472
Fax 58966 0
Email 58966 0
[email protected]
Contact person for public queries
Name 58967 0
Matthew Toumazou
Address 58967 0
Matthew Toumazou James Cook University 1 James Cook Drive, Townsville QLD 4811. Room 043 017.
Country 58967 0
Australia
Phone 58967 0
+61 7 4781 6472
Fax 58967 0
Email 58967 0
[email protected]
Contact person for scientific queries
Name 58968 0
Matthew Toumazou
Address 58968 0
Matthew Toumazou James Cook University 1 James Cook Drive, Townsville QLD 4811. Room 043 017.
Country 58968 0
Australia
Phone 58968 0
+61 7 4781 6472
Fax 58968 0
Email 58968 0
[email protected]

No information has been provided regarding IPD availability


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.