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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00506896
Enrollment
60
Registered
2007-07-25
Start date
2004-07-31
Completion date
2006-01-31
Last updated
2007-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, glucocorticoid, intraarticular injection, arthritis

Brief summary

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

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.

Interventions

Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
VAS for knee pain12 weeks post intervention

Secondary

MeasureTime frame
side and adverse effects, safety12 weeks post intervention

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026