At the primary end-point (12 months), the clinical effectiveness of physiotherapist-led exercise therapy is hypothesized to be significantly greater than a corticosteroïd injection. With anticipated greater positive effects on work absence (largest…
ID
Source
Brief title
Health condition
Shoulder complaints
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is pain and function (SPADI) over 12 months post-randomisation
Secondary outcome
The main secondary outcome is the incremental costs (MCQ and PCQ) per QALY gained over 12 months post-randomisation. other secondary outcomes include pain and function on other follow-up time points (6 weeks and 3, 6, 9 months after baseline), and global perceived effect, quality of life, side effects, sleep quality, work absence and health care utilisation at all follow-up time points.
Background summary
Rationale: There is an ambiguity in the treatment of shoulder complaints in general practice. Since 1999 the Dutch guideline for shoulder complaints recommends a local corticosteroid injection or referral to physiotherapy for persisting pain. However, more recent evidence found that corticosteroid injections only have a short-term effect on shoulder pain. Furthermore, the Dutch College of General Practitioners emphasize the need of high quality RCT’s on the effects of corticosteroid injections and physiotherapy to be able to base their recommendations on high quality evidence. Objective: The aim of this study is to assess the (cost-)effectiveness of a local corticosteroid injection versus physiotherapy-led exercise therapy over a 12 month follow-up period. The secondary aims of this study are the (cost-)effectiveness at 6 weeks, 3, 6, and 9 months. Study design: An open pragmatic randomized controlled trial with two parallel groups and a follow-up of 12 months after the allocated treatment. Study population: Patients who consulted their GP with a new episode of shoulder complaints (n=213). Intervention: A local shoulder injection with 40 mg triamcinolone acetonide or a 12-week physiotherapist-led exercise therapy program will be randomly allocated. Main study parameters/endpoints: The primary outcome measure is pain and function (SPADI) over 12 months post-randomisation. The secondary outcome is costs (MCQ and PCQ) over 12 months post-randomisation. Other Secondary outcomes include pain and function on other follow-up time points (6 weeks and 3, 6, 9 months after baseline), and global perceived effect, quality of life, side effects, sleep quality, work absence and health care utilisation at all follow-up time points.
Study objective
At the primary end-point (12 months), the clinical effectiveness of physiotherapist-led exercise therapy is hypothesized to be significantly greater than a corticosteroïd injection. With anticipated greater positive effects on work absence (largest costs item due to shoulder pain), the cost-effectiveness of physiotherapist-led exercise therapy is also hypothesized to be superior.
Study design
6 weeks, 3-6-9 and 12 months
Intervention
Corticosteroïd injection or a 12-week physiotherapist-led exercise therapy
Inclusion 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) corticosteroid injection or physiotherapist-led exercise therapy is indicated in this patient as recommended by the guideline for shoulder complaints issued by the NHG; 4) signed informed consent form.
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
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8854 |
| CCMO | NL71774.078.20 |
| OMON | NL-OMON52854 |
| OMON | NL-OMON52854 |