Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000466741
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
24/03/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
24/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial (RCT) to investigate the effectiveness of a public health campaign to increase people's confidence in becoming more active despite low back pain in comparison with no intervention.
Scientific title
It's ok to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people's confidence becoming more active despite low back pain?
Secondary ID [1] 306575 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 325468 0
Condition category
Condition code
Public Health 322851 322851 0 0
Health promotion/education
Musculoskeletal 322853 322853 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The video interventions are between 2 and 3 minutes long and have been designed specifically for this study. Both follow the same narrative that scientists would like to reassure the public that low back pain is common, and that evidence suggests it is safe to move despite back pain. The featured scientists report that they are unsure of how to convey these messages to the public, which leads to designers at the advertising agency brainstorming how to help deliver the key message that it is safe to move. The advertising agency personnel suggest a dance. The video cuts back to the scientists who are reluctant to endorse one specific movement, such as a dance and conclude that it does not matter what you do as long as you move. The video ends with the superimposed text, "It's safe to move", "Your backbone has backbone". The second video is the same as the first, except that when the advertising agency suggests the dance, the scientists try it out and to add humour, there are some video clips of the scientists dancing. Participants will access the intervention videos once only.

Participants will be provided with a link and expected to watch the video where they would usually access social media, for example at home, or on public transport. The study will be advertised through social media channels over a period of 6 months or until we achieve the required sample size. Participants will watch one of the intervention videos only.
This is a social media-based intervention.
We will assess and monitor adherence to the intervention, by analysing the information provided by the survey platform, including % of survey completed and the time spent on survey
Intervention code [1] 323004 0
Behaviour
Comparator / control treatment
All participants will be recruited via social media and asked to participate in a survey about low back pain. The survey will include a question to ask if the participant has low back pain or not at the time of completing the survey. People without low back pain will be provided with a scenario where they are asked to imagine that they have low back pain.

.The second video (with scientists dancing) will serve as the comparator.
Control group
Active

Outcomes
Primary outcome [1] 330635 0
The primary outcome will be item 10 of the patient self-efficacy Questionnaire (PSEQ) which asks participants to rate how confident they would feel to gradually become more active despite the pain with a range from 0 (not at all confident) to 6 (completely confident).
Timepoint [1] 330635 0
This outcome will be measured immediately in all participant
Secondary outcome [1] 407051 0
The secondary outcomes will be Factor 1 of the AxEL-Q Questionnaire. The AxEL-Q is a questionnaire designed to assess attitudes toward first-line care for low back pain, Factor 1 comprises nine items and evaluates Attitude toward staying active. The score range for Factor 1 is 0 to 54, with higher scores indicating a more positive attitude toward messages about staying active.
Timepoint [1] 407051 0
This outcome will be measured immediately in all participant groups.
Secondary outcome [2] 407052 0
To understand the helpfulness of the video, we will ask participants four questions rated on a 7- point Numeric Rating Scale.
Timepoint [2] 407052 0
This outcome will be measured immediately in all participant groups
Secondary outcome [3] 407204 0
We will evaluate engagement with the video by asking participants five Yes/No questions.
Timepoint [3] 407204 0
This outcome will be measured immediately
Secondary outcome [4] 407205 0
We will ask participants four open-ended questions to understand their experience watching the video. The questions have been developed specifically for this study
Timepoint [4] 407205 0
This outcome will be measured immediately

Eligibility
Key inclusion criteria
People will be eligible for inclusion in this RCT if they are over 18 years of age and fluent in written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
The participant will self-enrol in the trial and be unaware of which group they would be allocated at that time.
The allocation will be done using the survey platform Qualtrics, therefore the holder of the allocation schedule was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the Qualtrics survey platform, we will add a "randomiser" function to the survey flow. The "randomiser" element will automatically assign respondents to one of the three groups and the corresponding block of questions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2022
Actual
5/04/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
14/07/2022
Date of last data collection
Anticipated
7/11/2022
Actual
14/07/2022
Sample size
Target
1383
Accrual to date
Final
1933
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24629 0
New Zealand
State/province [1] 24629 0
Country [2] 24630 0
United Kingdom
State/province [2] 24630 0
Country [3] 24631 0
United States of America
State/province [3] 24631 0
Country [4] 24632 0
Netherlands
State/province [4] 24632 0
Country [5] 24633 0
Canada
State/province [5] 24633 0
Country [6] 24634 0
Brazil
State/province [6] 24634 0

Funding & Sponsors
Funding source category [1] 310907 0
Other Collaborative groups
Name [1] 310907 0
Maridulu Budyari Gumal (SPHERE)
Country [1] 310907 0
Australia
Primary sponsor type
Individual
Name
James McAuley
Address
Centre for Pain IMPACT
Neuroscience Research Australia
139 Barker Street
Randwick
NSW
2031
Country
Australia
Secondary sponsor category [1] 312199 0
None
Name [1] 312199 0
Address [1] 312199 0
Country [1] 312199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310469 0
UNSW HREC Executive
Ethics committee address [1] 310469 0
Ethics committee country [1] 310469 0
Australia
Date submitted for ethics approval [1] 310469 0
05/10/2021
Approval date [1] 310469 0
17/12/2021
Ethics approval number [1] 310469 0
HC210908

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

Contacts
Principal investigator
Name 117774 0
Prof James McAuley
Address 117774 0
Centre for Pain IMPACT, Neuroscience Research Australia, 139 Barker Street, Sydney, New South Wales, Australia 2031
Country 117774 0
Australia
Phone 117774 0
+61 2 93991266
Fax 117774 0
Email 117774 0
[email protected]
Contact person for public queries
Name 117775 0
James McAuley
Address 117775 0
Centre for Pain IMPACT, Neuroscience Research Australia, 139 Barker Street, Sydney, New South Wales, Australia 2031
Country 117775 0
Australia
Phone 117775 0
+61 2 93991266
Fax 117775 0
Email 117775 0
[email protected]
Contact person for scientific queries
Name 117776 0
James McAuley
Address 117776 0
Centre for Pain IMPACT, Neuroscience Research Australia, 139 Barker Street, Sydney, New South Wales, Australia 2031
Country 117776 0
Australia
Phone 117776 0
+61 2 93991266
Fax 117776 0
Email 117776 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 underlying published results only will be available on request from the corresponding author on completion of this trial.
When will data be available (start and end dates)?
Data will be available on request from the corresponding author immediately following publication and ending 5 years following main results publication.
Available to whom?
Data will be provided on a case-by-case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
data will be available for IPD meta-analyses,
How or where can data be obtained?
Data will be available on request from the corresponding author or primary sponsor on completion of this trial. [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15271Study protocolThe protocol will be published in a peer-reviewed journal  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIt's safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people's confidence becoming more active despite back pain.2022https://dx.doi.org/10.1136/bmjopen-2022-063250
N.B. These documents automatically identified may not have been verified by the study sponsor.