Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of intra-articular glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with Rheumatoid Arthritis

Detailed Description
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A randomized double-blind controlled study was conducted including 60 patients with RA. Patients were randomized to receive either a single intra-articular knee injection with triamcinolone hexacetonide 60 mg and xylocaine chloride 2% (1 mL) associated to a single intramuscular injection of 1 mL of xylocaine chloride 2% (IAI group) or 1 mL of xylocaine chloride 2% by intra-articular injection and a intramuscular injection of triamcinolone acetonide 60 mg and xylocaine chloride 2% (1 mL) (IM group). Evaluations were performed at baseline and 1, 4, 8 and 12 weeks post-intervention. The following instruments were used: the ACR 20%, 50 and 70% improvement criteria; VAS for knee morning stiffness, pain and edema; knee circumference and goniometry; Likert's scale of improvement (IVAS); daily use of oral glucocorticoid and NSAIDs, blood pressure and adverse effects.

Official Title
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Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: intraarticular injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid Arthritis diagnosed for more than 6 months 18 and 65 years Functional class II or III according to the ACR criteria VAS for knee pain higher than 5 Use of stable doses of oral corticosteroid for the last 30 days Use of stable doses of DMARDs for the last 3 months Active synovitis at least in one knee for at least the 30 days Exclusion Criteria: Non-controlled diabetes mellitus or hypertension Bacterial infection of any site Blood coagulation disorders Skin lesion on the affected knee History of previous surgical procedure in the knee Use of intra-muscular glucocorticoid in the last 30 days Intra-articular injection in the last 3 months Knee injection in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: intraarticular injection<br>* Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration<br>* Other names: Theracort®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for knee pain |  | 12 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side and adverse effects, safety |  | 12 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, glucocorticoid, intraarticular injection, arthritis