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

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: intraarticular injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00506896

0599/04

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 1 patient group

1

Active Comparator group

Treatment:

Drug: intraarticular injection