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Open Access Study protocol

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

Ramon PG Ottenheijm1*, Manuela A Joore2, Geert HIM Walenkamp3, René E Weijers4, Bjorn Winkens5, Jochen WL Cals1, Rob A de Bie6 and Geert-Jan Dinant1

Author Affiliations

1 Dept. of General Practice, CAPHRI School for Public Health and Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands

2 Dept. of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands

3 Dept. of Orthopaedic Surgery, Maastricht University Hospital, Maastricht, the Netherlands

4 Dept. of Radiology, Maastricht University Medical Centre, Maastricht, The Netherlands

5 Dept. of Methodology and Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands

6 Dept. of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands

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BMC Musculoskeletal Disorders 2011, 12:154  doi:10.1186/1471-2474-12-154

Published: 8 July 2011

Abstract

Background

Subacromial 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/Design

This 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.

Discussion

The 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.