Limits...
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.

Ottenheijm RP, Joore MA, Walenkamp GH, Weijers RE, Winkens B, Cals JW, de Bie RA, Dinant GJ - BMC Musculoskelet Disord (2011)

Bottom Line: Yet, the clinical cost-effectiveness of applying US in the management of SP in primary care has not been studied.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.Secondary outcomes are disease specific and generic quality of life, cost-effectiveness, and the adherence to the initial applied treatment.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General Practice, CAPHRI School for Public Health and Primary Care, Maastricht University, and Department of Orthopaedic Surgery, Maastricht University Hospital, PO Box 616, 6200 MD Maastricht, The Netherlands. ramon.ottenheijm@maastrichtuniversity.nl

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.

Show MeSH

Related in: MedlinePlus

Flowchart of the study
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC3141612&req=5

Figure 1: Flowchart of the study

Mentions: In a pragmatic design, which initially follows the guideline for SP of the DCGP[4], a study consisting of two phases will be carried out: a Qualification Period of two weeks followed by a randomised controlled trial (RCT) with a 50 week follow-up period (Figure 1). The Qualification period aims to filter out patients with a favorable natural course. During the 2-week Qualification period all patients are advised to start with paracetamol or NSAIDs in maximum dosage on a time contingent base, receive advice regarding activities of daily living, work, hobbies and sports. This advise fits within the first line treatment as recommended in the guideline for SP of the DCGP. Moreover, patients are referred for US of the shoulder to the radiology department of the Maastricht University Medical Centre (MUMC) or Orbis Medical Centre (OMC) in Sittard-Geleen, The Netherlands. Based on the qualification assessment at 2 weeks, patients with insufficient improvement qualify for the RCT. These patients are randomly assigned to the intervention or the control group. The therapies used in both groups are the same except that therapies used in the intervention group will be tailored based on the US results. Primary and secondary outcome measures will be assessed at baseline, 13, 26, 39 and 52 weeks after inclusion. Patient recruitment started in November 2010 and patients will be included until October 2012. The Medical Ethics Committee of the Maastricht University Medical Centre has approved this protocol (NTR2403). This trial is officially called the Maastricht Ultrasound Shoulder pain Trial (MUST).


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.

Ottenheijm RP, Joore MA, Walenkamp GH, Weijers RE, Winkens B, Cals JW, de Bie RA, Dinant GJ - BMC Musculoskelet Disord (2011)

Flowchart of the study
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3141612&req=5

Figure 1: Flowchart of the study
Mentions: In a pragmatic design, which initially follows the guideline for SP of the DCGP[4], a study consisting of two phases will be carried out: a Qualification Period of two weeks followed by a randomised controlled trial (RCT) with a 50 week follow-up period (Figure 1). The Qualification period aims to filter out patients with a favorable natural course. During the 2-week Qualification period all patients are advised to start with paracetamol or NSAIDs in maximum dosage on a time contingent base, receive advice regarding activities of daily living, work, hobbies and sports. This advise fits within the first line treatment as recommended in the guideline for SP of the DCGP. Moreover, patients are referred for US of the shoulder to the radiology department of the Maastricht University Medical Centre (MUMC) or Orbis Medical Centre (OMC) in Sittard-Geleen, The Netherlands. Based on the qualification assessment at 2 weeks, patients with insufficient improvement qualify for the RCT. These patients are randomly assigned to the intervention or the control group. The therapies used in both groups are the same except that therapies used in the intervention group will be tailored based on the US results. Primary and secondary outcome measures will be assessed at baseline, 13, 26, 39 and 52 weeks after inclusion. Patient recruitment started in November 2010 and patients will be included until October 2012. The Medical Ethics Committee of the Maastricht University Medical Centre has approved this protocol (NTR2403). This trial is officially called the Maastricht Ultrasound Shoulder pain Trial (MUST).

Bottom Line: Yet, the clinical cost-effectiveness of applying US in the management of SP in primary care has not been studied.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.Secondary outcomes are disease specific and generic quality of life, cost-effectiveness, and the adherence to the initial applied treatment.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General Practice, CAPHRI School for Public Health and Primary Care, Maastricht University, and Department of Orthopaedic Surgery, Maastricht University Hospital, PO Box 616, 6200 MD Maastricht, The Netherlands. ramon.ottenheijm@maastrichtuniversity.nl

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.

Show MeSH
Related in: MedlinePlus