Clinical trial NCT00506896: Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients
Official title: Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
glucocorticoid
intraarticular injection
arthritis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS for knee pain
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: side and adverse effects, safety
timeFrame: 12 weeks post intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Rheumatology Division, Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Monique S Konai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Rita V Furtado, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Marla F Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Jamil Natour, MD, PhD
role: STUDY_CHAIR
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