Intramuscular corticosteroid injection in hip osteoarthritis: a randomized controlled trial

Phase 4

Recruiting

Conditions: degenerative hip arthritis
degenerative hip joint disease
10023213

Registration Number: NL-OMON39512

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 135

Inclusion Criteria

1. A diagnosis of hip OA according to the cinical ACR criteria, including radiologic evidence of OA (kellgren-lawrence grading greater or equal than 2)
2. age > 40 years
3. Symptomatic disease for at least 6 months prior to enrolment
4. Persistent pain despite receiving normal pain medication (acetaminophen and/or NSAID) for at least 3 weeks. Pain severity (in rest or on walking) defined as a minimum score of 3 on the Numerical Rating Scale (NRS; 0-10 range)

Exclusion Criteria

Local or systemic infection precluding injection, diabetes mellitus, systemic arthritis, allergy to corticosteroid agent, use of oral corticosteroids, coagulopathy, anticoagulant therapy (cumarin type), peptic ulcer, previous intra-articular steroid injection into the index hip in the past 6 months, radiographic signs of osteonecrosis, pregnancy, lactating women, participation in other medical trials and on the waiting list for a hip replacement surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is the severity of pain in rest and pain at walking<br /><br>(NRS 0-10, 0 equals no pain) and WOMAC 3.1 pain subscale (0-100, 0 equals no<br /><br>pain) at 2 weeks follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary outcome measure are<br /><br>1. the primary outcome measure at the other follow-up moments (4, 6, 12 weeks)<br /><br>2 WOMAC 3.1 (5-point Likert) function and stiffness subscales. We will<br /><br>normalize the WOMAC function and the WOMAC stiffness subscale both to a 0 to<br /><br>100 score, where 0 equals no symptoms<br /><br>3 patients* global assessment (with use of a 7-point Likert scale: 1 = worse<br /><br>than ever to 7 = major improvement)<br /><br>4 a generic measure for quality of life using Euroqol<br /><br>5 difference in percentage of responders as defined by OMERACT-OARSI<br /><br>6 range of motion of the index hip<br /><br>7 specific adverse effects</p><br>