The Maastricht Ultrasound Shoulder pain trial (MUST): Ultrasound imaging as a diagnostic triage tool to improve management of patients with non-chronic shoulder pain in primary care

Abstract

BackgroundSubacromial disorders are considered to be one of the most common pathologies affecting the shoulder. Optimal therapy for shoulder pain (SP) in primary care is yet unknown, since clinical history and physical examination do not provide decisive evidence as to the patho-anatomical origin of the symptoms. Optimal decision strategies can be furthered by applying ultrasound imaging (US), an accurate method in diagnosing SP, demonstrating a clear relationship between diagnosis and available therapies. Yet, the clinical cost-effectiveness of applying US in the management of SP in primary care has not been studied. The aim of this paper is to describe the design and methods of a trial assessing the cost-effectiveness of ultrasound imaging as a diagnostic triage tool to improve management of primary care patients with non-chronic shoulder pain.Methods/DesignThis randomised controlled trial (RCT) will involve 226 adult patients with suspected subacromial disorders recruited by general practitioners. During a Qualification period of two weeks, patients receive care as usual as advised by the Dutch College of General Practitioners, and patients are referred for US. Patients with insufficient improvement qualify for the RCT. These patients are then randomly assigned to the intervention or the control group. The therapies used in both groups are the same (corticosteroid injections, referral to a physiotherapist or orthopedic surgeon) except that therapies used in the intervention group will be tailored based on the US results. Ultrasound diagnosed disorders include tendinopathy, calcific tendinitis, partial and full thickness tears, and subacromial bursitis. The primary outcome is patient-perceived recovery at 52 weeks, using the Global Perceived Effect questionnaire. Secondary outcomes are disease specific and generic quality of life, cost-effectiveness, and the adherence to the initial applied treatment. Outcome measures will be assessed at baseline, 13, 26, 39 and 52 weeks after inclusion. An economic evaluation will be performed from both a health care and societal perspective with a time horizon of 52 weeks.DiscussionThe results of this trial will give unique evidence regarding the cost-effectiveness of US as a diagnostic triage tool in the management of SP in primary care.

Ultrasound Imaging for Tailored Treatment of Patients With Acute Shoulder Pain

“…The design of the MUST study has been presented in detail elsewhere. 6 We included 129 patients with acute shoulder pain in whom the family physician suspected rotator cuff disease. Patients were eligible if they (1) had shoulder pain upon abduction with painful arc, (2) had symptoms having lasted for fewer than 3 months, (3) had no other episodes of shoulder pain in the previous 12 months, (4) were aged between 18 and 65 years.…”

“…Standardized ultrasound diagnostic criteria for pathology were used. 6 Ultrasound findings were prospectively evaluated for abnormalities of the rotator cuff, the long head of the biceps tendon, the subacromial-subdeltoid bursa, and the acromioclavicular joint, as well as for impingement.…”

“…Standardized ultrasound diagnostic criteria for pathology were used. 6 Ultrasound findings were prospectively evaluated for abnormalities of the rotator cuff, the long head of the biceps tendon, the subacromial-subdeltoid bursa, and the acromioclavicular joint, as well as for impingement.We calculated means and standard deviations for continuous variables and percentages for categorical variables. Linear and logistic regression analyses were performed to determine the association of age, sex, and occupation with rotator cuff disorders in univariate analysis, followed by multivariate analysis, and expressed as odds ratios (ORs).…”

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice

“…32 Patients were eligible if they had shoulder pain on abduction with painful arc; symptoms having lasted <3 months; no other episodes of shoulder pain in the previous 12 months and age between 18 and 65 years. Exclusion criteria were consultation or treatment for shoulder pain in the past 3 months; glenohumeral external rotation range of motion <45°as this is a reason to suspect a glenohumeral disorder like osteoarthritis or a frozen shoulder; history of fractures of the proximal humerus or acromion, dislocation and/or surgery of the affected shoulder; shoulder symptoms caused by rheumatic disease, suspected referred symptoms or extrinsic cause; history of depressive or anxiety disorders (negative prognostic factors) or pain catastrophising (irrational thought in believing pain is far worse than it actually is); inability to complete a questionnaire independently; unable to give informed consent (dementia or psychiatric disorders) and involved in disability or liability procedures.…”

“…32 The two study arms were treatment tailored to the ultrasound diagnosis or usual care (figure 1). The GP provided the allocated treatments.…”