Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000545167
Ethics application status
Approved
Date submitted
3/04/2019
Date registered
8/04/2019
Date last updated
11/03/2020
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding imaging reports for low back pain
Scientific title
Consumer understanding of terms used in imaging reports requested for low back pain
Secondary ID [1] 297439 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 311621 0
Spinal imaging 311622 0
Condition category
Condition code
Musculoskeletal 310246 310246 0 0
Other muscular and skeletal disorders
Public Health 310813 310813 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an internet-based survey of the general population that is asking participants about their attitudes and beliefs about a set of terms commonly used to describe findings of imaging for low back pain. No prior exposure to imaging reports is required. The survey provides common terms used in imaging reports (for example, 'disc bulge' and 'nerve root contact') and asks participants to rate them on a 5 point Likert scale related to 4 statements (for example, 'If I had an x-ray or scan of my back today because of back pain and this term was in the report, I would be worried that there is a serious problem with my back'). An explanation of imaging for low back pain is also given.

The survey is expected to take less than 10 minutes to complete.
Intervention code [1] 313697 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319133 0
Self reported understanding (comprehension) of commonly used terms in lumbar spine imaging reports. This is assessed through the question 'If I had an x-ray or scan of my back today because of back pain, I would need to look this term up to know what it means.' measured on a 5 point Likert scale from Strongly Disagree to Strongly Agree. This survey is designed specifically for this study, but the questions are based on other validated questionnaires where possible.
Timepoint [1] 319133 0
At time of survey completion
Secondary outcome [1] 367069 0
Worry about perceived seriousness of back pain related to radiology terms assessed by the survey on a 5 point Likert scale. This is assessed by the question 'If I had an x-ray or scan of my back today because of back pain, I would be worried that there is a serious problem with my back.' measured on a 5 point Likert scale from Strongly Disagree to Strongly Agree. This question is specifically designed for this study, but based on questions from validated questionnaires.
Timepoint [1] 367069 0
At time of survey completion
Secondary outcome [2] 369054 0
Worry about perceived persistence of back pain related to radiology terms assessed by the survey on a 5 point Likert scale. This is assessed by the question 'If I had an x-ray or scan of my back today because of back pain, I would be worried that my pain isn't going to get any better.' measured on a 5 point Likert scale from Strongly Disagree to Strongly Agree. This question is specifically designed for this study, but based on questions from validated questionnaires.
Timepoint [2] 369054 0
At time of survey completion
Secondary outcome [3] 369055 0
Kinesiophobia (fear of pain due to movement) related to radiology terms assessed by the survey on a 5 point Likert scale. This is assessed by the question 'If I had an x-ray or scan of my back today because of back pain, I would be afraid to move my back in case I did more damage.' measured on a 5 point Likert scale from Strongly Disagree to Strongly Agree. This question is specifically designed for this study, but based on questions from validated questionnaires.
Timepoint [3] 369055 0
At time of survey completion

Eligibility
Key inclusion criteria
All adult members of the general population with or without a history of lower back pain are eligible for this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
We will use multivariable regression to determine the association between the level of self-reported understanding, perceived seriousness and risk of persistence as well as the relationship between these factors and low back pain history and severity and the Back Beliefs Questionnaire (BBQ) score. Further exploratory analyses will be performed as required.

Our target sample size of 650 is based on a minimum required sample size of 590 participants to detect a 70% prevalence of not understanding with a 95% confidence interval width of 10%. We plan to have 10 predictors in our multivariable model and a sample size of 650 will give us a ratio of more than 30 observations per predictor. This is considered to be sufficient to achieve stability of regression coefficients, particularly when the effect size is small and the number of predictors greater than six (Betsy and Carmen, 2007). Increasing the sample size to 650 also enables us to retain adequate power in the event of partial or non-completed surveys. With this sample size, a multivariable linear regression with 10 predictors will be able to detect effect size as small as R2 = 0.02 with power of 80% (a=0.05), indicating that the sample size is sufficient to identify any clinically meaningful predictors of perceived persistence, severity and kinesiophobia related to low back pain.

Reference:
Betsy, L.M. and R.W.V.V. Carmen (2007). Understanding Power and Rules of Thumb for Determining Sample Sizes. Tutorials in Quantitative Methods for Psychology. 3(2): p. 43-50.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2019
Actual
9/04/2019
Date of last participant enrolment
Anticipated
26/04/2019
Actual
18/04/2019
Date of last data collection
Anticipated
26/04/2019
Actual
18/04/2019
Sample size
Target
650
Accrual to date
Final
677
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21294 0
New Zealand
State/province [1] 21294 0
All
Country [2] 21295 0
Canada
State/province [2] 21295 0
All
Country [3] 21296 0
United States of America
State/province [3] 21296 0
All
Country [4] 21297 0
United Kingdom
State/province [4] 21297 0
All

Funding & Sponsors
Funding source category [1] 302011 0
Government body
Name [1] 302011 0
National Health and Medical Research Council
Country [1] 302011 0
Australia
Primary sponsor type
Individual
Name
Professor Rachelle Buchbinder
Address
Monash School of Public Health and Preventive Medicine, Cabrini Institute
4 Drysdale St
Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 301796 0
None
Name [1] 301796 0
Address [1] 301796 0
Country [1] 301796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302687 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 302687 0
Ethics committee country [1] 302687 0
Australia
Date submitted for ethics approval [1] 302687 0
18/01/2019
Approval date [1] 302687 0
07/02/2019
Ethics approval number [1] 302687 0
13896

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

Contacts
Principal investigator
Name 91058 0
Prof Rachelle Buchbinder
Address 91058 0
Department of Clinical Epidemiology, Cabrini Institute
4 Drysdale St
Malvern VIC 3144
Country 91058 0
Australia
Phone 91058 0
+61 3 9508 3499
Fax 91058 0
Email 91058 0
[email protected]
Contact person for public queries
Name 91059 0
Caitlin Farmer
Address 91059 0
Department of Clinical Epidemiology, Cabrini Institute
4 Drysdale St
Malvern VIC 3144
Country 91059 0
Australia
Phone 91059 0
+61 3 9508 3490
Fax 91059 0
Email 91059 0
[email protected]
Contact person for scientific queries
Name 91060 0
Rachelle Buchbinder
Address 91060 0
Department of Clinical Epidemiology, Cabrini Institute
4 Drysdale St
Malvern VIC 3144
Country 91060 0
Australia
Phone 91060 0
+61 3 9508 3499
Fax 91060 0
Email 91060 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 that underlie the results of articles after de-identification (text, tables, figures and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal
How or where can data be obtained?
Proposals should be directed to [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.