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Open Access Study protocol

Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial

Desirée MJ Dorleijn1*, Pim AJ Luijsterburg1, Max Reijman2, Margreet Kloppenburg3, Jan AN Verhaar2, Patrick JE Bindels1, P Koen Bos2 and Sita MA Bierma-Zeinstra1

Author Affiliations

1 Department of General Practice, Erasmus MC, University Medical Center, Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands

2 Department of Orthopaedics, Erasmus MC, University Medical Center, Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands

3 Department of Rheumatology, LUMC, PO Box 9600, 2300 RC Leiden, The Netherlands

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BMC Musculoskeletal Disorders 2011, 12:280  doi:10.1186/1471-2474-12-280

Published: 12 December 2011

Abstract

Background

Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed.

The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication.

Methods/Design

This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years) with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline) injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics). Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle.

Discussion

This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started.

Trial Registration

This trial is registered in the Dutch Trial Registry: number NTR2966.