Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified Health Condition 2: null- Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Methyl-prednisolone acetate 80mg injectable suspension: Intra-articular injection given once in the knee joint only (Not repeated)
Control Intervention1: Triamcinolone Acetonide 80 mg I
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: All patients having RA as per the 2010 ACR/EULAR criteria for classification of rheumatoid arthritis (score of >= 6/10) or spondyloarthropathy as per the European Spondyloarthropathy Study Group (ESSG) criteria having acutely swollen knee joint defined as knee joint swelling of >=1 week and < 24 weeks duration.
Exclusion criteria
Exclusion criteria: 1. Patients who have received intra-articular corticosteroid in the same joint in last 3 months 2. Patients who do not consent for the procedure 3. Overlying skin infection 4. Fracture site 5. Severely compromised immune status 6. Suspected bacteremia 7. Suspected infectious arthritis 8. History of hypersensitivity to intra-articular corticosteroids 9. Multiple intra-articular injections being given at the same time (other joints apart from the knee also being injected at the same time) 10. Severely damaged joints as assessed by i. Severe joint space narrowing on X-ray ii. Marked crepitus iii. Marked deformity not explained by synovitis alone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to relapse after the intra-articular steroid injection over a period of 24 weeks from baseline. Relapse will be defined as recurrence of pain similar to or more than that present prior to the intra-articular injection persisting for â?¥ 1 weekTimepoint: The time to relapse after the intra-articular steroid injection over a period of 24 weeks from baseline. Relapse will be defined as recurrence of pain similar to or more than that present prior to the intra-articular injection persisting for â?¥ 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects that will be noted include: a) Vasovagal syncope/flushing during the procedure b) Skin hypopigmentation or atrophy c) Infection d) Hematoma at the site of injection Timepoint: 0,4,12,24 weeks;i. Change in patient-reported pain and swelling in the target joint at 4,12 and 24 weeks from baseline using a numerical rating scale.Timepoint: 4,12 and 24 weeks;ii. Change in range of movement in the target joint(extension and flexion) at 24 weeks from baselineTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Varun Dhir
PGIMER
Outcome results
None listed