Double dose treatment: Corticosteroid injection therapy in arthritis

Phase 4

Completed

Conditions: RA
rheumatoide artritis
10003816

Registration Number: NL-OMON34658

Lead Sponsor: Ziekenhuisgroep Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

•Arthritis patients, RA or other causes of chronic arthritis (not osteoarthritis and not gout) with an indication for local injection with corticosteroid due to active arthritis in knee joint.
•Patients should have stable anti-arthritic co-medication, no changes will be made during the trial.
•Patients need to score at least *matig* at a 5-point Likert scale at the initial questionnaire at t = 0 otherwise no significant difference can be measured.

Exclusion Criteria

•Contraindication for local injection with corticosteroid (infection, relevant skin lesion, uncontrolled diabetes mellitus)
•Chronic (>3 months) or current use of more than 10mg prednisolone or equivalent daily.
•No informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: percentage of patients with sustained good response; i.e.<br /><br>symptomatic relief after local corticosteroid injection in knee joint, measured<br /><br>as a difference (a positive change of at least 2 points on a 5 point scale)<br /><br>between t = 0 and t = 12 weeks on a 5 point Likert scale (Burden of arthritis<br /><br>symptoms: very much, much, moderate, little, none; as determined by a question<br /><br>to the patient, see CRF) at at least 2 consecutive weeks including week 12, for<br /><br>each included patient. </p><br>

Secondary Outcome Measures