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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29422
Enrollment
135
Registered
2011-07-04
Start date
2011-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip osteoarthritis corticosteroid injection intramuscular

Interventions

Intervention group: One injection triamcinolone acetate 40 mg (1ml) intramuscular gluteal region. Control group: One saline injection (1ml) intramuscular gluteal region.

Sponsors

Erasmus MC Rotterdam, Department of General Practice
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pain reduction at 2 weeks follow-up (NRS 0-10, WOMAC pain subscale).

Secondary

MeasureTime frame
1. 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.

Contacts

Public ContactP.A.J. Luijsterburg

Erasmus Medical Center Department of General Practice Room NA1905 PO Box 2040

p.luijsterburg@erasmusmc.nl+31 10 7037513

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)