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Intramuscular corticosteroid injection in hip osteoarthritis: A randomized controlled trial.


- candidate number10000
- NTR NumberNTR2966
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jul-2011
- Secondary IDs2011-115 METC Erasmus MC Rotterdam
- Public TitleIntramuscular corticosteroid injection in hip osteoarthritis: A randomized controlled trial.
- Scientific TitleIntramuscular corticosteroid injection in hip osteoarthritis: A randomized controlled trial.
- ACRONYMHOCI trial
- hypothesisWhat 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?
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hip, Corticosteroid injection, Intramuscular
- Inclusion criteriaPatients 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).
- Exclusion criteriaPatients 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-jan-2015
- Target number of participants135
- InterventionsIntervention group: One injection triamcinolone acetate 40 mg (1ml) intramuscular gluteal region.
Control group: One saline injection (1ml) intramuscular gluteal region.
- Primary outcomePain reduction at 2 weeks follow-up (NRS 0-10, WOMAC pain subscale).
- Secondary outcome1. Pain reduction at 4, 6 and 12 weeks follow-up (NRS, WOMAC pain subscale);
2. Effect on function (WOMAC function subscale), mobility (WOMAC stiffness subscale);
3. Perceived recovery (7-point Likert scale);
4. Response rate according to OARSI/OMERACT criteria;
5. Side effects;
6. Difference between primary and secondary care setting.
- TimepointsAll 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.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. P.A.J. Luijsterburg
- CONTACT for SCIENTIFIC QUERIESDr. P.A.J. Luijsterburg
- Sponsor/Initiator Erasmus Medical Center, Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds, Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryResearch 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.
- Main changes (audit trail)
- RECORD4-jul-2011 - 6-dec-2015


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