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
Bron
Verkorte titel
Aandoening
Shoulder complaints
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is pain and function (SPADI) over 12 months post-randomisation
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
6 weeks, 3-6-9 and 12 months
Onderzoeksproduct en/of interventie
Corticosteroïd injection or a 12-week physiotherapist-led exercise therapy
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8854 |
| CCMO | NL71774.078.20 |
| OMON | NL-OMON52854 |
| OMON | NL-OMON52854 |