What is the effect on pain reduction for pain in rest and pain at walking of an intramuscular injection in the upper gluteal region with 40 mg triamcinolone acetate versus injection with saline water in patients with hip osteoarthritis (OA) at short…
ID
Bron
Verkorte titel
Aandoening
hip
osteoarthritis
corticosteroid injection
intramuscular
Ondersteuning
Fonds NutsOhra
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pain reduction at 2 weeks follow-up (NRS 0-10, WOMAC pain subscale).
Achtergrond van het onderzoek
Research question:
What is the effect on pain reduction for pain in rest and pain at walking of an intramuscular injection in the upper gluteal region with 40 mg triamcinolone acetate versus injection with saline water in patients with hip osteoarthritis (OA) at short-term follow-up?
Study design:
Prospective, multicenter, double blind, randomized controlled trial.
Study population:
Patients with hip OA presenting in primary (GP) or secondary (orthopedics) care will be eligible for inclusion if they are > 40 years and have persistent pain despite usual oral pain medication.
Intervention:
The patients will be randomized in 2 groups, stratified for setting (primary or secondary). The intervention group receives one intramuscular triamcinolone acetate 40mg intramuscular gluteal injection; the control group receives one saline intramuscular gluteal injection.
Primary outcome measure:
Pain measured with NRS (0-10) and WOMAC pain subscale.
Doel van het onderzoek
What is the effect on pain reduction for pain in rest and pain at walking of an intramuscular injection in the upper gluteal region with 40 mg triamcinolone acetate versus injection with saline water in patients with hip osteoarthritis (OA) at short-term follow-up?
Onderzoeksopzet
All outcome measures will be obtained at baseline and 2,4,6 and 12 weeks.
At baseline and at 12 weeks there will also be a physical examination.
Onderzoeksproduct en/of interventie
Intervention group: One injection triamcinolone acetate 40 mg (1ml) intramuscular gluteal region.
Control group: One saline injection (1ml) intramuscular gluteal region.
Publiek
Department of General Practice<br>
Room NA1905<br>
PO Box 2040<br>
P.A.J. Luijsterburg
Rotterdam 3000 CA
The Netherlands
+31 10 7037513
p.luijsterburg@erasmusmc.nl
Wetenschappelijk
Department of General Practice<br>
Room NA1905<br>
PO Box 2040<br>
P.A.J. Luijsterburg
Rotterdam 3000 CA
The Netherlands
+31 10 7037513
p.luijsterburg@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients will be recruited from primary care (general practitioner) or secondary care (outpatient orthopedic clinic). They will be eligible if they:
1. Have a diagnosis of OA of the hip according to clinical ACR criteria, including radiologic signs of OA (Kellgren-Lawrence grading equal or greater than 2);
2. Are older than 40 years;
3. Have symptomatic disease for at least 6 months prior to enrolment;
4. Have persistent pain (score equal or greater than 3, NRS 0-10) despite receiving optimal doses of oral pain medication (acetaminophen and/or NSAID).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients will be excluded if they have:
1. Inability to understand Dutch questionnaire;
2. Local or systemic infection;
3. Diabetes mellitus;
4. Systemic arthritis;
5. Allergy to corticosteroid agent;
6. Use of oral corticosteroids;
7. Coagulopathy;
8. Anticoagulant therapy (coumarin type);
9. Peptic ulcer;
10. Previous intra-articular injection into the index hip the past 6 months;
11. Radiologic signs of osteonecrosis;
12. Pregnancy or lactating women;
13. Participation in other medical trials;
14. On the waiting list for total hip arthroplasty.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2825 |
| NTR-old | NTR2966 |
| Ander register | METC Erasmus MC Rotterdam : 2011-115 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |