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Trial registered on ANZCTR


Registration number
ACTRN12621001370897
Ethics application status
Approved
Date submitted
10/09/2021
Date registered
11/10/2021
Date last updated
27/01/2022
Date data sharing statement initially provided
11/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic labels and advice for shoulder pain: How does this impact people’s perceived need for shoulder surgery?
Scientific title
Effects of diagnostic labels for rotator cuff disease and advice on people’s perceived need for shoulder surgery: An online-randomised controlled study
Secondary ID [1] 305283 0
NHMRC Investigator Grant APP1194105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 323583 0
Condition category
Condition code
Musculoskeletal 321130 321130 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The whole study will be conducted online. Participants will enter the survey by clicking a link to the study from their email.

Once participants enter the survey, read the participant information sheet, provide consent (if eligible), and complete a baseline questionnaire, they will be directed to read a vignette describing a person with shoulder pain presenting to a health professional and imagine that they are the person being described in the vignette. This scenario was taken from our previous trial[1] which received input from clinicians that commonly manage patients with shoulder pain.

Labels and messages
After reading the hypothetical scenario, participants will be randomised (1:1:1:1 ratio) to receive one of four combinations of diagnostic labels and advice from a health professional.

The interventions include:
- Being labelled with a bursitis and given evidence based advice
- Being labelled with a rotator cuff tear and given evidence based advice
- Being labelled with a bursitis and given standard online advice

The two labels are rotator cuff tear and bursitis. Both labels will be accompanied by a brief explanation of the label as per our previous trial:
• “Rotator cuff tear. A rotator cuff tear is a tear in one of the shoulder tendons.”
• “Bursitis. Bursitis is inflammation of a fluid-filled sac called a bursa in the shoulder.”

The two messages of advice are:
• Message #1 (evidence-based advice): “I am not worried that there is anything serious going on here because your pain is not related to severe trauma. I am also not worried that you have arthritis in your shoulder or a specific condition called frozen shoulder that causes severe pain and stiffness. Your pain should gradually improve over time by itself. It is recommended that you avoid activities that aggravate your pain but continue to use your arm so your shoulder does not stiffen up.”
• Message #2 (standard online advice): “Without proper treatment, your symptoms can persist for months or years, and usually become worse over time. Most people with your symptoms respond to treatment within four to six weeks, especially if an injection is part of the treatment.”

Message #1 was taken from our previous trial[1] and based on guideline recommendations for the management of rotator cuff disease[2]. For Message #2, we searched for examples of advice on webpages identified in a content analysis we recently conducted examining the quality of online information for shoulder surgery. We prioritised reputable sources (e.g. Government, University) that presented opposing advice to Message #1. Message #2 was adapted from a Harvard Medical School webpage titled ‘Rotator Cuff Injury’. We removed any reference to a diagnosis so the advice could be presented alongside the rotator cuff tear and bursitis labels. Both messages of advice will be delivered by a world-renowned orthopaedic surgeon via a pre-recorded video. This video will be embedded within the online survey. Participants will be required to press a 'play' button to watch the video. Participants will have access to the script and will be able to re-watch the video. To ensure participants watch the video (i.e. enoucrage adherence), participants will not be able to proceed to the next part of the survey until the whole video has been viewed.

The next part of the survey will include the assessment of outcomes measures. The entire survey will take 10-15 minutes to complete.

References
1. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45.
2. Kulkarni RN, Gibson JA, Brownson P, Thomas M, Rangan A, Carr AJ, Rees JL. Subacromial shoulder pain BESS / BOA Patient Care Pathways. Shoulder Elbow. 2015:0(0);1–9.
Intervention code [1] 321688 0
Behaviour
Intervention code [2] 321834 0
Prevention
Comparator / control treatment
The control intervention is being labelled with a rotator cuff tear and given standard online advice
Control group
Active

Outcomes
Primary outcome [1] 328909 0
Perceived need for shoulder surgery (including the main effect of the labels and advice, and the interaction between labels and advice - as per a 2x2 factorial trial) assessed by the following question adapted from previous labelling studies[1-3]: “Based on what your healthcare provider has told you, do you think you need surgery to relieve your symptoms?” Participants respond to this question by selecting a number from 0 (‘definitely do not’) to 10 (‘definitely do’). Based on previous trials, we consider scores of 0-3 as ‘low’ (e.g. low perceived need for surgery), scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [1] 328909 0
Immediately after viewing the hypothetical scenario
Secondary outcome [1] 400839 0
Perceived need for imaging assessed by the following question adapted from previous labelling studies[1-3]: "Based on what your healthcare provider has told you, do you think you need diagnostic imaging of your shoulder (e.g. X-ray, MRI, ultrasound)?" Participants respond to this question by selecting a number from 0 (‘definitely do not’) to 10 (‘definitely do’). Based on previous trials, we consider scores of 0-3 as ‘low’, scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [1] 400839 0
Immediately after viewing the hypothetical scenario
Secondary outcome [2] 400840 0
Perceived need for an injection assessed by the following question adapted from previous labelling studies[1-3]: "Based on what your healthcare provider has told you, do you think you need an injection to relieve your symptoms?" Participants respond to this question by selecting a number from 0 (‘definitely do not’) to 10 (‘definitely do’). Based on previous trials, we consider scores of 0-3 as ‘low’, scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [2] 400840 0
Immediately after viewing the hypothetical scenario
Secondary outcome [3] 400841 0
Perceived need for a second opinion assessed by the following question adapted from previous labelling studies[1-3]: "Based on what your healthcare provider has told you, do you think you need a second opinion from another general practitioner or physiotherapist?" Participants respond to this question by selecting a number from 0 (‘definitely do not’) to 10 (‘definitely do’). Based on previous trials, we consider scores of 0-3 as ‘low’, scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [3] 400841 0
Immediately after viewing the hypothetical scenario
Secondary outcome [4] 400842 0
Perceived need to see a specialist assessed by the following question adapted from previous labelling studies[1-3]: "Based on what your healthcare provider has told you, do you think you need to see a specialist (e.g. shoulder surgeon, rheumatologist) for your shoulder pain?" Participants respond to this question by selecting a number from 0 (‘definitely do not’) to 10 (‘definitely do’). Based on previous trials, we consider scores of 0-3 as ‘low’, scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [4] 400842 0
Immediately after viewing the hypothetical scenario
Secondary outcome [5] 400843 0
Perceived seriousness of the condition assessed by the following question adapted from previous labelling studies[1-3]: "Based on what your healthcare provider has told you, do you think that [insert label here] is a serious condition for you to have?" Participants respond to this question by selecting a number from 0 (‘not at all serious’) to 10 (‘extremely serious’). Based on previous trials, we consider scores of 0-3 as ‘low’, scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [5] 400843 0
Immediately after viewing the hypothetical scenario
Secondary outcome [6] 400844 0
Perceived recovery expectations assessed by the following question adapted from previous labelling studies[1-3]: "Based on what your healthcare provider has told you, how likely do you think it is that your shoulder pain will be fully recovered in 6 months?" Participants respond to this question by selecting a number from 0 (‘not at all likely’) to 10 (‘extremely likely’). Based on previous trials, we consider scores of 0-3 as ‘low’, scores of 4-6 as ‘moderate’, and scores of 7-10 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [6] 400844 0
Immediately after viewing the hypothetical scenario
Secondary outcome [7] 400845 0
Perceived impact on attendance at work assessed by the following question adapted from previous labelling studies[1-3]: "Please read the following statement about work and indicate how strongly you disagree or agree with it- My work might harm my shoulder" Participants respond to this question by selecting a number from 0 (‘completely agree’) to 6 (‘completely disagree’). Based on previous trials, we consider scores of 0-2 as ‘low’, scores of 2-4 as ‘moderate’, and scores of 5-6 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [7] 400845 0
Immediately after viewing the hypothetical scenario
Secondary outcome [8] 400846 0
Perceived impact on performance at work assessed by the following question adapted from previous labelling studies[1-3]: "Please read the following statement about work and indicate how strongly you disagree or agree with it- I should not do my normal work with my present pain" Participants respond to this question by selecting a number from 0 (‘completely agree’) to 6 (‘completely disagree’). Based on previous trials, we consider scores of 0-2 as ‘low’, scores of 2-4 as ‘moderate’, and scores of 5-6 as ‘high’.

References
1. Copp T, McCaffery K, Azizi L, Doust J, Mol BW, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Hum Reprod. 2017;32(4):876-884.
2. Fisher A, Bonner C, Biankin AV, Juraskova I. Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial. Prev Med. 2012;55(5):514-520.
3. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [8] 400846 0
Immediately after viewing the hypothetical scenario
Secondary outcome [9] 400847 0
Words and feelings when hearing the advice assessed by the following question adapted from our previous labelling study[1]: "When you hear the advice from the surgeon on the video, what words or feelings does this make you think of? Please list." [Free text response]

References
1. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [9] 400847 0
Immediately after viewing the hypothetical scenario
Secondary outcome [10] 400848 0
Perceived treatment for the advice assessed by the following question adapted from our previous labelling study[1]: "After hearing the advice from the surgeon on the video, what treatment (s) (if any) do you think a person who hears this advice needs? Please list." [Free text response]

References
1. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45
Timepoint [10] 400848 0
Immediately after viewing the hypothetical scenario

Eligibility
Key inclusion criteria
(a) self-identify as currently having shoulder pain,
(b) rate their shoulder pain over the past week as 1 or more on a scale of 0-10, and
(c) did not have a traumatic shoulder injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Unable to read and type English
(b) Being <18 years old

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)
Participants will be randomised through the online survey platform Qualtrics (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)
1:1:1:1 ratio for the four groups. Randomisation will be performed via computerised sequence generation through the online platform Qualtrics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The four group means will be compared using a 2 × 2 (label × advice) linear regression models, with previous surgery (a binary variable) and pain scores on a 0-10 scale entered into the model. To strongly control the family-wise Type I error rate, a Bonferroni correction will be used (i.e., paired differences will be declared significant if the two-tailed p<0.017 and confidence intervals will be calculated as 98.3% intervals). We will need 1,840 participants to have 80% power to detect a main effect of labels and advice of 1.0 point and an interaction effect of 1.0 point, using a standard deviation of 3, a correlation between previous surgery and outcome of 0.27, and 24% dropout from our previous trial (where dropouts represent the percentage of people who are randomised but do not complete the entire survey)[1]. If more than 5% of data are missing for a particular analysis, multiple imputation will be used to account for missing data provided the missing at random assumption appears plausible[2]. Questions about words or feelings participants think of when hearing the advice in the video and what treatment they think a person who hears this advice needs will be analysed using content analysis.

References
1. Zadro JR, O’Keeffe M, Ferreira GE, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45.
2. Kenward MG, Carpenter J. Multiple imputation: current perspectives. Stat Methods Med Res. 2007;16(3):199-218.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2022
Actual
13/01/2022
Date of last participant enrolment
Anticipated
31/05/2022
Actual
20/01/2022
Date of last data collection
Anticipated
31/05/2022
Actual
20/01/2022
Sample size
Target
1840
Accrual to date
Final
2028
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24108 0
New Zealand
State/province [1] 24108 0
Country [2] 24109 0
United States of America
State/province [2] 24109 0
Country [3] 24110 0
Canada
State/province [3] 24110 0
Country [4] 24111 0
United Kingdom
State/province [4] 24111 0

Funding & Sponsors
Funding source category [1] 309655 0
Government body
Name [1] 309655 0
National Health and Medical Research Council
Country [1] 309655 0
Australia
Primary sponsor type
Individual
Name
Joshua Zadro
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] 310670 0
None
Name [1] 310670 0
Address [1] 310670 0
Country [1] 310670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309422 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 309422 0
Ethics committee country [1] 309422 0
Australia
Date submitted for ethics approval [1] 309422 0
10/09/2021
Approval date [1] 309422 0
11/11/2021
Ethics approval number [1] 309422 0

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

Contacts
Principal investigator
Name 114106 0
Dr Joshua Zadro
Address 114106 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 114106 0
Australia
Phone 114106 0
+61 449906121
Fax 114106 0
Email 114106 0
joshua.zadro@sydney.edu.au
Contact person for public queries
Name 114107 0
Joshua Zadro
Address 114107 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 114107 0
Australia
Phone 114107 0
+61 449906121
Fax 114107 0
Email 114107 0
joshua.zadro@sydney.edu.au
Contact person for scientific queries
Name 114108 0
Joshua Zadro
Address 114108 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 114108 0
Australia
Phone 114108 0
+61 449906121
Fax 114108 0
Email 114108 0
joshua.zadro@sydney.edu.au

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 post-intervention data as required
When will data be available (start and end dates)?
Following publication of this study (anticipated Feb 2023). There is no end date. Data will be kept in perpetuity.
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?
Through contacting the principal investigator, Dr Joshua Zadro, via email joshua.zadro@sydney.edu.au


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.