(Cost-)Effectiveness of local corticosteroid injection versus exercise therapy for shoulder complaints: a pragmatic randomized, 12 months comparative parallel-group trial
- Conditions
- shoulder complaintshoulder pain10023213
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 808
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measures will be pain and function (captured together in<br /><br>SPADI total score) over 12 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome measure will be incremental cost per quality adjusted<br />life year (QALY) gained, using both the medical as well as the societal<br />perspective, over 12 months post-randomisation. Medical costs will be measured<br />using the Medical Cost Questionnaire (MCQ) and societal costs will be measured<br />using the Productivity Cost Questionnaire (PCQ). QALY will be measured using<br />the five-level version of the well-validated EuroQol Five-Dimensional<br />Questionnaire (EQ-5D-5L) score.<br />Furthermore, secondary outcome measures will include short and long-term (6<br />weeks, 3,6,9, en 12 months) assessment of global perceived effect, quality of<br />life, side effects, sleep quality, work absence, and healthcare utilisation. In<br />addition, side effects and any serious adverse events (SAE) will be assessed. </p>