None listed
Conditions
Brief summary
Shoulder pain affects 7-26% of people at any given time[1] and is the third most common musculoskeletal condition seen in primary care[2]. Rotator cuff disease is an umbrella diagnosis that captures 85% of shoulder pain cases[3]. Diagnostic labels influence management preferences for rotator cuff disease. Our online randomised controlled trial (n=1,308) found that people who were told they had a rotator cuff tear had higher perceived need for shoulder surgery and imaging compared to those told they had bursitis[4]. However, we only investigated the isolated effect of labels. In clinical practice, some health professionals could give patients a diagnostic label followed by positive prognostic information and simple management advice (e.g. temporarily avoid activities that aggravate the pain, continue to move the arm). Others could give patients a diagnostic label followed by advice (e.g. take prolonged rest, stop going to work) that increase patients’ fear and perceived need for unnecessary care (e.g. surgery). The primary aim of this online randomised controlled trial is to examine the effects of diagnostic labels and advice on people with rotator cuff disease, and interactions between labels and advice, on perceived need for shoulder surgery. Secondary outcomes include perceived need for imaging, perceived need for an injection, perceived need for a second opinion, perceived need to see a specialist, perceived seriousness of the condition, recovery expectations, and perceived impact on attendance and performance at work. We hypothesise that both the bursitis label (compared to rotator cuff tear) and evidence-based advice (compared to standard advice) will reduce perceived need for surgery. We also hypothesise that there will be a supra-additive effect of providing both evidence-based advice and the bursitis label. References 1. Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, 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, Keinanen-Kiukaanniemi S, Takala J. 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, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005;44(6):800-5. 4. 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.
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 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.
Sponsors
Study design
Eligibility
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
Exclusion criteria
(a) Unable to read and type English (b) Being <18 years old