Intramuscular corticosteroid injections in hip osteoarthritis: a double-blinded randomized controlled trial - HOCI study

• Conditions: Hip osteoarthritis; MedDRA version: 12.1Level: LLTClassification code 10018407Term: Glucocorticoids normal

• Registration Number: EUCTR2011-000213-39-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The inclusion criteria will be
1. a diagnosis of OA of the hip according to the clinical ACR criteria, including radiologic evidence of OA (Kellgren-Lawrence (K-L) score ge 2)
2. Age > 40 years
3. Symptomatic disease for at least 6 months prior to enrolment
4. Persistent pain despite receiving optimal doses of normal pain medication (acetaminophen (3 gr/day) and/or a NSAID) for at least 3 weeks. Pain severity (in rest or on walking) defined as a minimum score of 3 on NRS (0-10 range)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The exclusion criteria include local or systemic infection precluding injection, diabetes mellitus, systemic arthritis, allergy to corticosteroid agent, use of oral corticosteroids, coagulopathy, anticoagulant therapy (cumarine type), peptic ulcer, previous IA steroid injection into the index hip the past 6 months, radiologic signs of osteonecrosis, pregnancy, participation in other medical trials, and on the waiting list for a total hip arthroplasty.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified