Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000197639
Ethics application status
Approved
Date submitted
14/02/2023
Date registered
23/02/2023
Date last updated
7/06/2023
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Advice and education for rotator cuff-related shoulder pain
Scientific title
The effect of advice and education on reassurance for people with rotator cuff-related shoulder pain: a three-arm randomised online experiment
Secondary ID [1] 308993 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 329024 0
Condition category
Condition code
Musculoskeletal 326008 326008 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 randomised (1:1:1 ratio) to receive one of three interventions (explained more below). The randomisation process will be created using Qualtrics survey software. Participants will be shown the following message:

“We will now show you some advice that is commonly provided by health professionals to people with shoulder pain. The advice does not completely mimic what would be provided in a consultation with a health professional as it is significantly shorter. It does however portray the key messages that a health professional would give. We want you to think carefully about the advice and key messages, and answer some questions about it. Please click on the video to watch a health professional providing this advice. Below the video there is the script if you missed anything in the video or would like to read the advice.”

Interventions will be delivered by the same physiotherapist via a pre-recorded video. Participants will be able to re-watch the video if needed and will have access to the script. Across the three groups, the pre-recorded video will cover two overarching themes: “what causes shoulder pain”, and “what can be done for shoulder pain”. Each video will go for 2-3 minutes. The time to complete the entire survey and watch the video will be 10-15 minutes. We will monitor the time participants spend watching the video as a measure of adherence.

INTERVENTION 1: ‘Best practice advice’ which highlights most shoulder pain isn’t serious, pain isn’t a good indicator of tissue damage, and recommends simple self-management strategies

Few clinical practice guidelines for the management of rotator cuff-related shoulder pain mention advice and education. For this reason, we adapted the advice provided in the GRASP trial (ISRCTN16539266; defined as ‘best practice advice’). GRASP was a 2x2 factorial trial testing a progressive exercise programme with a single session of best practice advice, with or without corticosteroid injection, for adults with rotator cuff-related shoulder pain. The advice booklet in this trial was 32-pages and covered numerous topics (e.g. common treatments for rotator cuff-related shoulder pain, possible mechanisms and symptoms, self-management advice, activity modification, advice on pain during and after exercise). Given the nature of our online trial, it was not feasible to present the whole booklet to participants. Instead, we focussed on a few key messages highlighting most shoulder pain isn’t serious, pain isn’t a good indicator of tissue damage, and recommending simple self-management strategies. Here is the advice:

*What causes shoulder pain?*
Shoulder pain is very common. Most cases are not serious requiring urgent medical attention (like a fracture or dislocation) yet still cause a lot of pain. The exact cause of most shoulder pain is still being learnt about. However, an important point to remember is that even if a scan shows large changes in the structures around the shoulder (for example, tendon tears or swelling), these changes do not always lead to pain or loss of shoulder function. Tears are common in people with and without pain and become more common with age. This shows that the pain is the main problem, not the amount of injury to the shoulder.

*What can be done for shoulder pain?*
There are several ways that you can help your shoulder problem. We will not cover all possible treatment options, but the most common options and the ones supported by good evidence. In a real-world consultation with a health professional, they would provide more information about these options, including information about the dose and how frequently you should use treatment. We are only going to provide a brief overview to give you an idea of the best available options.

• You can try using heat or cold over the area as this can ease pain
• You can try some over-the-counter pain medicines, such as paracetamol or ibuprofen
• You can gradually increase your activity levels. This may sound like the opposite of what you should do because if we have pain when being active, we tend to do less to avoid pain. However, less activity can make our muscles weaker and our joints stiffer. This in turn can make our pain worse
• If there is an activity or movement that makes your shoulder pain worse, try to find a different way of doing it. For example, using the other arm to reach to a high cupboard
• You can try exercise. Some people can get improvements within a few weeks of exercising, while others need to work at it for several months. If you are unsure about what exercises you can or should do, you can see a physiotherapist for some advice. You do not need to avoid pain while exercising, just work to a level that you can tolerate. It is okay if an exercise causes a small amount of pain while performing it (for example, less than 5/10 pain), provided your pain reduces to a level you can easily tolerate once you stop the exercise. It is NOT okay if an exercise causes pain while performing it and the pain does not settle (or gets worse) once you stop the exercise. If this happens, you should choose a different or easier exercise next time until your shoulder gets stronger. Some people find that their muscles and joints ache for a few days after starting a new exercise or when increasing the amount of exercise they do. This is a normal response and usually gets better over time
• Surgery is generally not recommended for people with shoulder pain. It is often a last resort reserved for a small number of people

If pain becomes worse than usual, we call it a flare-up. It is very normal to have flare-ups of pain. Sometimes there might be a reason why you have a flare-up, for example maybe you have been overdoing it with your exercises. Sometimes these flare-ups just come out of the blue, for no real reason you can think of. It is important to remember, most of the time more pain does not mean that there has been more damage.


INTERVENTION 2: Best practice advice plus pain science education

Participants will receive best practice advice plus pain science education. The pain science education was adapted from a National Health Service (NHS) patient leaflet ‘Pain Explained’. ‘Pain Explained’ included key messages which formed the basis of our advice. We also used some pain science education messages that were used in the GRASP trial (ISRCTN16539266). Here is the advice:

*What causes shoulder pain?*

Same as ‘best practice advice’ plus:

All pain experiences are real and a normal response to what our brain thinks is a threat. People often assume that the more pain we feel, the more damage there must be. However, we know that this is NOT true because:
• Two people with the same type of injury report different pain levels
• Some people with significant damage have no pain, for example, sporting or war injuries
• There are many times when little-to-no damage can be seen on scans (for example, X-Ray) but people report considerable pain

So how and why do we feel pain?
All over our body there are millions of detectors at the ends of nerves that detect changes in the body. When these detectors perceive changes in pressure, temperature or chemicals, a signal travels up the nerve to the spinal cord and then to the brain. The brain then has to make sense of the information it receives. If the brain concludes that there is a potential or actual threat, you may experience pain.

Pain is a useful part of the body’s protective system. It is like a car alarm that goes off to warn the owner the car is in danger. However, sometimes when pain is ongoing the pain system can become over-sensitive, like a car alarm that goes off when someone walks past it. This can happen when your perception of pain is negatively influenced by your environment, memory, thoughts, feelings, lifestyle and beliefs.

*What can be done for shoulder pain?*
The good news is that being active may help the pain system become less sensitive. One way of managing pain is to distract yourself and focus your attention more on things you enjoy. If you imagine pain is like a ticking clock in a room, you notice it less when you are busy or distracted by other things. Distraction works best when it is something enjoyable such as ringing a friend or doing a crossword.

There are also several other ways that you can help your shoulder problem.


Same as ‘best practice advice'
Intervention code [1] 325438 0
Treatment: Other
Comparator / control treatment
‘Structure-focused pain advice’ highlighting structural changes are responsible for pain and should be targeted with treatment

Structure-focused pain advice was based on a webpage from the American Academy of Orthopaedic Surgeons titled ‘Shoulder Pain and Common Shoulder Problems’ (https://orthoinfo.aaos.org/en/diseases--conditions/shoulder-pain-and-common-shoulder-problems/). It was identified through a content analysis we conducted examining the quality of online information for shoulder surgery. We focused on key messages highlighting structural changes are responsible for pain and should be targeted with treatment. Here is the advice:

*What causes shoulder pain?*
The shoulder is made up of several joints that combine with tendons and muscles to allow a wide range of motion in the arm — from scratching your back to throwing the perfect pitch. Mobility has its price, however. It may lead to increasing problems with instability or impingement of the soft tissue or bony structures in your shoulder, resulting in pain. The most common form of shoulder problem is impingement, tendon inflammation (bursitis or tendinitis), or tendon tears, described more in the following paragraphs.

The bursa is a small fluid-filled sac that cushions tendons as they slide over bone. Shoulder impingement occurs when the arm is lifted away from the body and the top of the shoulder blade (acromion) then puts pressure on the bursa and shoulder tendons underneath (rotator cuff tendons).

Sometimes, excessive use of the shoulder leads to inflammation and swelling of the bursa (bursitis). This often occurs in combination with inflammation of tendons in the shoulder (rotator cuff tendinitis). Generally, this is caused by excessive throwing or other overhead activities during work or sport or degenerative diseases like arthritis or repetitive wear and tear due to age.

Tendons can also tear. This may result from a sudden injury, long-term overuse, and advancing age. Tears can be partial or completely separate the tendon from its attachment to bone.

*What can be done for shoulder pain?*
Your doctor may prescribe medication to reduce inflammation and pain. If medication is prescribed to relieve pain, it should be taken only as directed. Your doctor may also recommend injections of numbing medicines or steroids to relieve pain.

Surgery may be required to resolve some shoulder problems. Certain types of shoulder problems, such as some rotator cuff tears, may not benefit from exercise. In these cases, surgery may be recommended fairly early."

This video will go for 2-3 minutes. The time to complete the entire survey and watch the video will be 10-15 minutes. We will monitor the time participants spend watching the video as a measure of adherence.


Control group
Active

Outcomes
Primary outcome [1] 333864 0
One primary outcomes will be a question measuring reassurance, assessed on a 0-10 scale (0 = not reassured at all; 10 = completely reassured):
• “Based on the advice you received, how reassured do you feel that there is no serious condition causing your shoulder pain?”
Timepoint [1] 333864 0
Outcome data will be collected immediately after participants have watched the video.
Primary outcome [2] 333910 0
One primary outcomes will be a question measuring reassurance, assessed on a 0-10 scale (0 = not reassured at all; 10 = completely reassured):
• “Based on the advice you received, how reassured do you feel that continuing with your daily activities is safe?”
Timepoint [2] 333910 0
Outcome data will be collected immediately after participants have watched the video.
Secondary outcome [1] 418536 0
We will explore reasons for feeling reassured with the following question: “What message(s) from the advice reassured you? If the advice did not reassure you at all, write N/A in the text box below.”
Timepoint [1] 418536 0
Immediately after participants have watched the video
Secondary outcome [2] 418537 0
We will assess the similarity between the advice given in the trial to advice participants have previously received from a health professional with the following question: “Is the advice you just received similar to the advice previously given to you by a health professional(s)?” (Yes/No/Unsure/I have not received advice from a health professional before)
Timepoint [2] 418537 0
Immediately after participants have watched the video
Secondary outcome [3] 418538 0
We will measure intentions to stay active on a 0-10 scale (0 = definitely not; 10 = definitely do).
Timepoint [3] 418538 0
Immediately after participants have watched the video
Secondary outcome [4] 418539 0
This outcome is relevance and usefulness of the advice as assessed by four questions on from the Credibility and Expectancy questionnaire (Credibility range: 0–40; higher scores indicate higher treatment credibility).
Timepoint [4] 418539 0
Immediately after participants have watched the video
Secondary outcome [5] 418540 0
Participants will be asked how relevant the advice provided to them was with one question: “To what extent does the information that you received addressed your concerns?” (0 = did not address my concerns at all; 10 = addressed my concerns completely)
Timepoint [5] 418540 0
Immediately after participants have watched the video
Secondary outcome [6] 418541 0
Participants will be the following open-ended question exploring their feelings evoked by the interventions:
• “What did you dislike about the advice you received?”
Timepoint [6] 418541 0
Immediately after participants have watched the video
Secondary outcome [7] 418716 0
We will measure intentions to see a health professional on a 0-10 scale (0 = definitely not; 10 = definitely do).
Timepoint [7] 418716 0
Immediately after participants have watched the video
Secondary outcome [8] 418717 0
We will measure intentions to see a surgeon on a 0-10 scale (0 = definitely not; 10 = definitely do).
Timepoint [8] 418717 0
Immediately after participants have watched the video
Secondary outcome [9] 418718 0
We will measure intentions to request imaging on a 0-10 scale (0 = definitely not; 10 = definitely do).
Timepoint [9] 418718 0
Immediately after participants have watched the video
Secondary outcome [10] 418719 0
Participants will be the following open-ended question exploring their feelings evoked by the interventions:
• “What did you like about the advice you received?”
Timepoint [10] 418719 0
Immediately after participants have watched the video
Secondary outcome [11] 418720 0
Participants will be the following open-ended question exploring their feelings evoked by the interventions:
• “If your health professional gave you this advice, how would it make you feel?”
Timepoint [11] 418720 0
Immediately after participants have watched the video
Secondary outcome [12] 418721 0
Participants will be the following open-ended question exploring their treatment needs evoked by the interventions:
• “If your health professional gave you this advice, what treatments (if any) do you think you would need?”
Timepoint [12] 418721 0
Immediately after participants have watched the video

Eligibility
Key inclusion criteria
(a) self-identify as currently having shoulder pain;
(b) rate their shoulder pain over the past week as greater than or equal to 1 on a scale of 0-10;
(c) have shoulder pain around the anterolateral part of the shoulder and upper arm; and
(d) report that they have not been diagnosed by a health professional with adhesive capsulitis, glenohumeral osteoarthritis, glenohumeral instability, a shoulder fracture or dislocation, or cancer or infection in the shoulder;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) pain <1 on a 0-10 scale
(b) report that they have been diagnosed by a health professional with either adhesive capsulitis, glenohumeral osteoarthritis, glenohumeral instability, a shoulder fracture or dislocation, or cancer or infection in the shoulder;

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 (1:1:1 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 ratio for the threegroups. 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will summarise all data using descriptive statistics (eg means and standard deviations for continuous variables, frequencies and proportions for categorical variables). Multivariable linear regression will be used to estimate the effect of the three types of advice on reassurance (adjusted for baseline pain intensity and symptoms of anxiety), and treatment intentions, credibility and relevance (adjusted for baseline pain intensity). Chi2 tests will be used to investigate differences in outcomes between the three advice groups for dichotomous and categorical outcomes. We will follow intention-to-treat principles to analyse the data. All analyses will be conducted using Stata BE Version 17.1 (StataCorp LLC, College Station, Texas, USA). Responses to free-text questions will be analysed using content analysis, a well-accepted method allowing us to report the frequency of themes expressed in response to these questions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
1/06/2023
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
2118
Accrual to date
1000
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25262 0
New Zealand
State/province [1] 25262 0
Country [2] 25263 0
Canada
State/province [2] 25263 0
Country [3] 25264 0
United States of America
State/province [3] 25264 0
Country [4] 25265 0
United Kingdom
State/province [4] 25265 0

Funding & Sponsors
Funding source category [1] 313205 0
Government body
Name [1] 313205 0
National Health and Medical Research Council
Country [1] 313205 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] 314926 0
None
Name [1] 314926 0
Address [1] 314926 0
Country [1] 314926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312436 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312436 0
Ethics committee country [1] 312436 0
Australia
Date submitted for ethics approval [1] 312436 0
14/02/2023
Approval date [1] 312436 0
13/04/2023
Ethics approval number [1] 312436 0

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

Contacts
Principal investigator
Name 124662 0
Dr Joshua Zadro
Address 124662 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 124662 0
Australia
Phone 124662 0
+61 449906121
Fax 124662 0
Email 124662 0
joshua.zadro@sydney.edu.au
Contact person for public queries
Name 124663 0
Joshua Zadro
Address 124663 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 124663 0
Australia
Phone 124663 0
+61 449906121
Fax 124663 0
Email 124663 0
joshua.zadro@sydney.edu.au
Contact person for scientific queries
Name 124664 0
Joshua Zadro
Address 124664 0
Institute for Musculoskeletal Health, Level 10 North, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW, 2050
Country 124664 0
Australia
Phone 124664 0
+61 449906121
Fax 124664 0
Email 124664 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 2024). 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

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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
5123Study results articleYeshttps://doi.org/10.1097/j.pain.0000000000003102 https://journals.lww.com/pain/abstract/2024/04000/... [More Details]

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