Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000364673
Ethics application status
Approved
Date submitted
27/03/2023
Date registered
13/04/2023
Date last updated
20/06/2023
Date data sharing statement initially provided
13/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of three different forms of advice for acute low back pain on reassurance outcomes: a three-arm trial
Scientific title
The effects of three different forms of advice for acute low back pain on reassurance outcomes: a three-arm trial
Secondary ID [1] 309309 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 329496 0
Condition category
Condition code
Musculoskeletal 326433 326433 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will watch a pre-recorded video in which a physiotherapist member of the study team will deliver the information. Participants will have access to the video once from their computer and/or smartphone and/or tablet. We will monitor the time participants spent on the video as a measure of adherence to the intervention.

Participants randomised to guideline-based will watch the video on guideline-based advice only. Participants randomised to Guideline-based advice + pain science education-based advice will watch a video where both guideline-based and pain science education advice are provided together.

1) Guideline-based advice
The messages in the guideline-based advice group will be based on resources available for consumers developed by the Australian Commission of Quality and Safety in Health Care (ACQSHC) for their low back pain clinical care standard. The developed resources for consumers and key messages reflect those form clinical practice guidelines. The pre-recorded video in this group has a duration of 1 min 38s.

2) Guideline-based advice + pain science education-based advice
In addition to the guideline-based advice intervention described above, this group will receive pain science education-based advice. In addition to guideline-based advice, this group will receive messages that address key learning statements recognised by consumers as important concepts related to pain science education: (i) pain is a protective feeling, (ii) pain and tissue damage are poorly related, (iii) when it comes to pain, everything matters, (iv) when pain persists it becomes overprotective, (v) I can retrain my pain system to be less protective, (vi) learning how pain works is an effective treatment, (vii) active strategies are better than passive strategies, and (viii) all pain is real no matter what is causing it. The video in this group has a duration of 3min 48s.
Intervention code [1] 325744 0
Treatment: Other
Comparator / control treatment
Participants will watch a pre-recorded video in which a physiotherapist member of the study team will deliver the information. Participants will have access to the video once from their computer and/or smartphone and/or tablet. We will monitor the time participants spent on the video as a measure of adherence to the intervention

Participants randomised to Guideline-based + Ergonomics-based advice will watch a video where both guideline-based advice and ergonomics-based advice are provided together.

Guideline-based advice + Ergonomics-based advice
The messages in the ergonomics-based advice will be based on consumer resources available on the HealthDirect website. HealthDirect provides medical and health information for patients and consumers and is supported by several Australian Government partners, including the Commonwealth Government and 6 of the 7 Australian States and Territories. The video has a duration of 2min 17s.
Control group
Active

Outcomes
Primary outcome [1] 334270 0
Reassurance outcome: "How reassured do you feel that there is no serious condition causing your back pain?"

This outcome will be measured on a 0-10 scale (0= not reassured at all; 10 = completely reassured)
Timepoint [1] 334270 0
Immediately after the intervention
Primary outcome [2] 334349 0
Reassurance outcome: How reassured are you that continuing with your daily activities is safe?

This outcome will be measured on a 0-10 scale (0= not reassured at all; 10 = completely reassured)
Timepoint [2] 334349 0
Immediately after the intervention
Secondary outcome [1] 420079 0
Perceived risk of developing chronic pain

This outcome will be measured on a 0% - 100% scale (0= No risk; 100% = very large risk)
Timepoint [1] 420079 0
Immediately after intervention
Secondary outcome [2] 420080 0
Need for bed rest

This outcome will be measured on a 0-10 scale (0= Definitely do not; 10 = Definitely do)

As reported by:
O'Keeffe M, Ferreira GE, Harris IA, Darlow B, Buchbinder R, Traeger AC, Zadro JR, Herbert RD, Thomas R, Belton J, Maher CG. Effect of diagnostic labelling on management intentions for non-specific low back pain: A randomized scenario-based experiment. Eur J Pain. 2022 Aug;26(7):1532-1545.
Timepoint [2] 420080 0
Immediately after intervention
Secondary outcome [3] 420081 0
Intentions to see a health professional

This outcome will be measured on a 0-10 scale (0= Definitely do not; 10 = Definitely do)

As reported by:
O'Keeffe M, Ferreira GE, Harris IA, Darlow B, Buchbinder R, Traeger AC, Zadro JR, Herbert RD, Thomas R, Belton J, Maher CG. Effect of diagnostic labelling on management intentions for non-specific low back pain: A randomized scenario-based experiment. Eur J Pain. 2022 Aug;26(7):1532-1545.
Timepoint [3] 420081 0
Immediately after intervention
Secondary outcome [4] 420082 0
intentions to see a specialist

This outcome will be measured on a 0-10 scale (0= Definitely do not; 10 = Definitely do)


As reported by:
O'Keeffe M, Ferreira GE, Harris IA, Darlow B, Buchbinder R, Traeger AC, Zadro JR, Herbert RD, Thomas R, Belton J, Maher CG. Effect of diagnostic labelling on management intentions for non-specific low back pain: A randomized scenario-based experiment. Eur J Pain. 2022 Aug;26(7):1532-1545.
Timepoint [4] 420082 0
Immediately after intervention
Secondary outcome [5] 420083 0
Need for imaging

This outcome will be measured on a 0-10 scale (0= Definitely do not; 10 = Definitely do)


As reported by:
O'Keeffe M, Ferreira GE, Harris IA, Darlow B, Buchbinder R, Traeger AC, Zadro JR, Herbert RD, Thomas R, Belton J, Maher CG. Effect of diagnostic labelling on management intentions for non-specific low back pain: A randomized scenario-based experiment. Eur J Pain. 2022 Aug;26(7):1532-1545.
Timepoint [5] 420083 0
Immediately after intervention
Secondary outcome [6] 420084 0
Credibility of intervention (measured with the Credibility section of the Credibility and Expectancy questionnaire)
Timepoint [6] 420084 0
Immediately after intervention
Secondary outcome [7] 420085 0
Relevance of the advice.

Participants will be asked how relevant the advice provided to them was with one question: “To what extent did the information address your concerns?” (0 = did not address my concerns at all; 10 = addressed my concerns completely)
Timepoint [7] 420085 0
Immediately after the intervenion
Secondary outcome [8] 420086 0
Feelings, thoughts, and expectations evoked by the advice

This outcome will be collected as two open-ended questions: "1. At this point, how much do you really feel that the advice will help you to reduce your back pain?; and 2. After receiving this advice, how much improvement in your back pain symptoms do you really feel will occur? "
Timepoint [8] 420086 0
Immediately after the intervention

Eligibility
Key inclusion criteria
* Self-reported current acute low back pain (duration of symptoms of up to 6 weeks)
* Pain intensity of at least 1 (out of 10)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Having been diagnosed by a doctor with cancer, fracture in the lumbar spine, infection in the lumbar spine, cauda equina syndrome

* Having undergone lumbar surgery

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised through the online survey platform Qualtrics (1:1:1 ratio; concealed to investigators).

Randomisation will occur automatically once a participant enters the survey. Those recruiting participants via email will not be aware of the randomisation sequence. Hence, allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed via computerised sequence generation through the online platform Qualtrics at a 1:1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will follow intention-to-treat principles to analyse the data. We will estimate the effect of the three types of advice on reassurance outcomes using multivariable linear regression models for all primary, secondary outcomes, and process measures. All analyses will be adjusted by age and baseline pain intensity and by the baseline values of the outcome variable when applicable. If appropriate, missing outcome data will be imputed using multiple imputation methods.

Pre-planned subgroup analyses subgroup analyses will be performed by adding an interaction term between the candidate moderator variable and the co-primary outcomes to the multivariable linear regression models. The following candidate moderators will be investigated:

* Health literacy (using the single item health literacy screener, range 1-5). We will dichotomise scores using suggested cut-offs (<2 and >= 2)
* Predicted probability of developing chronic pain on co-primary outcomes The predicted probability of developing chronic pain will be modelled as a continuous variable.

The "Feelings, thoughts, and expectations evoked by the interventions" outcomes will be assessed using content analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2023
Date of last participant enrolment
Anticipated
Actual
20/04/2023
Date of last data collection
Anticipated
Actual
20/04/2023
Sample size
Target
1842
Accrual to date
Final
2313
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25346 0
United States of America
State/province [1] 25346 0
Country [2] 25347 0
New Zealand
State/province [2] 25347 0
Country [3] 25348 0
United Kingdom
State/province [3] 25348 0

Funding & Sponsors
Funding source category [1] 313502 0
Government body
Name [1] 313502 0
National Health and Medical Research Council
Country [1] 313502 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 315278 0
None
Name [1] 315278 0
Address [1] 315278 0
Country [1] 315278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312690 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312690 0
Ethics committee country [1] 312690 0
Australia
Date submitted for ethics approval [1] 312690 0
09/01/2023
Approval date [1] 312690 0
15/03/2023
Ethics approval number [1] 312690 0
2023/112

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

Contacts
Principal investigator
Name 125574 0
Dr Giovanni Ferreira
Address 125574 0
Institute for Musculoskeletal Health
KGV Building (C39) Level 10 North, Missenden Road, Camperdown, NSW 2050
Country 125574 0
Australia
Phone 125574 0
+61 2 86276691
Fax 125574 0
Email 125574 0
[email protected]
Contact person for public queries
Name 125575 0
Giovanni Ferreira
Address 125575 0
Institute for Musculoskeletal Health
KGV Building (C39) Level 10 North, Missenden Road, Camperdown, NSW 2050
Country 125575 0
Australia
Phone 125575 0
+61 2 86276691
Fax 125575 0
Email 125575 0
[email protected]
Contact person for scientific queries
Name 125576 0
Giovanni Ferreira
Address 125576 0
Institute for Musculoskeletal Health
KGV Building (C39) Level 10 North, Missenden Road, Camperdown, NSW 2050
Country 125576 0
Australia
Phone 125576 0
+61 2 86276691
Fax 125576 0
Email 125576 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?
Baseline and outcome data as required
When will data be available (start and end dates)?
Following publication of manuscript (late 2023) with no end date
Available to whom?
Anyone who requests it with a reasonable reason and will put in a formal ethics request to use the data
Available for what types of analyses?
To be decided based on the request
How or where can data be obtained?
By contacting the principal investigator: [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.