Comparison of between two steroid injections given in swollen knee joints

Phase 4

Completed

Conditions: Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecifiedHealth Condition 2: null- Rheumatoid Arthritis
Spondyloarthritis

Registration Number: CTRI/2015/09/006187

Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse effects that will be noted include: <br/ ><br>a) Vasovagal syncope/flushing during the procedure <br/ ><br>b) Skin hypopigmentation or atrophy <br/ ><br>c) Infection <br/ ><br>d) Hematoma at the site of injection <br/ ><br>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