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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]

NHMRC Investigator Grant APP1194105

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

shoulder pain

Condition category

Condition code

Musculoskeletal

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]

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]

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]

Outcome data will be collected immediately after participants have watched the video.

Primary outcome [2]

Timepoint [2]

Outcome data will be collected immediately after participants have watched the video.

Secondary outcome [1]

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]