shoulder complaint shoulder pain
Conditions
Interventions
Patients in the RCT will be randomized to either a local corticosteroid
injection or referral for physiotherapist-led exercise therapy
Patients randomized to the corticosteroid injection, will get a
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 NHG 4) signed informed consent form.
Exclusion criteria
Exclusion criteria: 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 vaccine 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures will be pain and function (captured together in SPADI total score) over 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measure will be incremental cost per quality adjusted life year (QALY) gained, using both the medical as well as the societal perspective, over 12 months post-randomisation. Medical costs will be measured using the Medical Cost Questionnaire (MCQ) and societal costs will be measured using the Productivity Cost Questionnaire (PCQ). QALY will be measured using the five-level version of the well-validated EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) score. Furthermore, secondary outcome measures will include short and long-term (6 weeks, 3,6,9, en 12 months) assessment of global perceived effect, quality of life, side effects, sleep quality, work absence, and healthcare utilisation. In addition, side effects and any serious adverse events (SAE) will be assessed. | — |
Countries
Netherlands
Outcome results
None listed