All inflammatory arthritidies Musculoskeletal Diseases Arthritis
Conditions
Interventions
Intra-articular corticosteroid injection either guided by musculoskeletal ultrasound or clinical examination.
Sponsors
Newcastle Hospitals NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who fulfil the American Rheumatology Association (ARA) Criteria for Rheumatoid Arthritis (RA) or have an established diagnosis of inflammatory arthritis 2. Age greater than 16 years 3. Presentation with an exacerbation of pain and/or stiffness and/or local findings of synovitis (at least two out of the three) of one of either the shoulder, elbow, wrist, knee or ankle joint (hip is excluded as we believe it should only be injected with imaging guidance) 4. Patients must be able to comply with the protocol and give their written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Radiological evidence of severe joint disease as assessed by previous x-ray of the affected joint 2. Patients receiving treatment for RA and not stabilised on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or corticosteroid therapy for one month or longer 3. Evidence of co-existent sepsis 4. A second joint requiring immediate corticosteroid injection 5. An acute flare of RA deemed severe enough by the patient?s supervising clinician to require an alteration in DMARD therapy 6. Use of intra-articular or intra-muscular steroids in the 28 days prior to study entry 7. Allergy to corticosteroids or contrast material
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the degree of improvement in loss of function at day 14 measured using a visual analogue scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Clinical: a. The degree of improvement in pain and in stiffness at day 14 b. The number of responders (patients who improve but do not relapse) at day 14 c. The degree of improvement in pain, stiffness and loss of function at six weeks d. The number of responders at six weeks and at three months e. The time to relapse as measured by the time from the joint injection to the first documentation of relapse of joint pain and/or stiffness (as assessed by patient and investigator) f. Improvement in movement of joint in all planes (as assessed by gonioimeter) at day 14 and week six g. The safety endpoint is the occurrence of tissue atrophy, nerve or vascular damage or septic arthritis 2. Radiological: a. The number of accurately injected joints as assessed by plain radiography b. The degree in reduction of ultrasound findings of joint effusion, synovial thickness and power Doppler signal in the injected joint 3. Laboratory: a. The reduction in C-reactive protein at 14 days b. The reduction in serum MMP-1 and MMP-3 at 14 days c. The reduction in serum C-terminal telopeptide of type I collagen (CTX) (a marker of bone resorption) and N-propeptide of type I collagen (PINP) (a marker of bone formation) at 14 days | — |
Countries
United Kingdom
Outcome results
None listed