Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- VAS for knee pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Intervention: intraarticular injection (Drug)
Outcomes
Primary Outcomes
VAS for knee pain
Time Frame: 12 weeks post intervention
Secondary Outcomes
- side and adverse effects, safety(12 weeks post intervention)