(Cost-)Effectiveness of local corticosteroid injection versus exercise therapy for shoulder complaints: a pragmatic randomized, 12 months comparative parallel-group trial - the SIX-study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 808 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•In order to be eligible to participate in this study, a patient must meet all
•of the following criteria:
•1) contacted their GP due to a new episode of shoulder pain (ICPC L92 or L08
•with unequivocal diagnosis of shoulder complaints)
•2) aged 18 years and over
•3) has an indication for corticosteroid injection or physiotherapist-led
•exercise therapy as recommended by the guideline for shoulder complaints by the
•4) signed informed consent form.

•1) They are outside the scope of the NHG guideline (eg, shoulder complaints due
•to recent serious trauma, malignity*s, systemic diseases, neurological or
•cardial diseases)
•2) There is a history of significant shoulder trauma (eg, dislocation, fracture
•or full thickness tear requiring surgery)
•3) They have received a corticosteroid injection or physiotherapy for shoulder
•complaints in the last 6 months
•4) local or systemic infection, after recent vaccination with live attenuated
•5) coagulopathy, use of anticoagulants
•6) A history of gastric ulcer
•7) Use of CYP3A-inductors
•8) Pregnancy
•9) Use of oral corticosteroids
•10) Allergy to corticosteroids or to anesthetics of the amide type or to the
•respective preservative (methyl or propyl parahydroxybenzoate or their
•metabolite para-aminobenzoic acid) or to sulfite;
•11) Unable to complete questionnaires in Dutch

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