None listed
Conditions
Brief summary
Shoulder pain affects up to one in four people at any time(1) and is a common reason for people to visit a health professional.(2) Rotator cuff-related shoulder pain is the most common cause of shoulder pain (~85%)(3) and is an umbrella diagnosis that captures pathology related to the rotator cuff (e.g. tendinopathy, tear, tendinitis, calcific tendinitis) or subacromial bursa (e.g. bursitis). Advice and education are recommended in clinical practice guidelines for most musculoskeletal conditions. For low back pain, 86% of guidelines recommend advice to maintain normal activities, 72% recommend reassurance on the favourable prognosis of low back pain, and 92% recommend against bed rest.(5) For neck pain, 73% of guidelines recommend advice to stay active and to avoid rest for greater than three days.(6) Yet for rotator cuff-related shoulder pain, only one guideline recommends advice to resume usual activities and providing information about the benefits and harms of treatment options.(7) This is likely due to a paucity of trials evaluating advice/education as an intervention. The primary aim of this study is to investigate the comparative effectiveness of three forms of advice on reassurance in people with rotator cuff-related shoulder pain. We also aim to: - Investigate the effectiveness of three forms of advice on intentions to stay active, see a health professional, see a specialist, and request imaging - Investigate the credibility and relevance of three forms of advice - Explore people’s feelings and perceived treatment needs evoked by three forms of advice. We hypothesise best-practice advice plus pain science education will be more reassuring than best practice advice alone and structure focused advice, and have a more beneficial effect on the other secondary outcomes. REFERENCES 1. Luime JJ, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. 2. Rekola KE, et al. Use of primary health services in sparsely populated country districts by patients with musculoskeletal symptoms: consultations with a physician. J Epidemiol Community Health. 1993;47(2):153-7. 3. Ostor AJ, et al. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatol. 2005;44(6):800-5. 4. Whittle S, Buchbinder R. In the clinic. Rotator cuff disease. Ann Intern Med. 2015;162(1):Itc1-15. 5. Oliveira CB, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018;27(11):2791-803. 6. Parikh P, et al. Comparison of CPG’s for the diagnosis, prognosis and management of non-specific neck pain: a systematic review. BMC Musculoskelet Dis. 2019;20(1):81. 7. Doiron-Cadrin P, et al. Shoulder Rotator Cuff Disorders: A Systematic Review of Clinical Practice Guidelines and Semantic Analyses of Recommendations. Arch Phys Med Rehabil. 2020;101(7):1233-42
Interventions
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'
Sponsors
Study design
Eligibility
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;
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;