Difference in indometacin and prednisolone in the treatment of gouty arthritis

Not Applicable

Completed

• Conditions: Gouty arthritis; Musculoskeletal Diseases; Gout

• Registration Number: ISRCTN45724113
• Lead Sponsor: Health, Welfare and Food Bureau (Hong Kong)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Aged greater than 18 years, either sex
2. Presenting to the Emergency Department between 9 am and 4 pm, Monday to Friday, from 1st January 2010 to 31st December 2011 with an acute arthritis suggestive of gout
3. Present within 3 days of symptom onset
4. Have a clinical diagnosis of an acute monoarthritis suggestive of gout
5. For the purpose of this study the diagnosis of acute gout is made if BOTH of the following TWO criteria are met:
5.1. Criteria 1: The presence of rapid onset of severe pain, swelling, tenderness and erythema of an affected joint, which is maximal by 6 to 12 hours
5.2. Criteria 2: The presence of one or more of the following:
5.2.1. Metatarsal-phalangeal (MTP) joint involvement (podagra); or
5.2.2. Knee or ankle joint involvement; or wrist or elbow joint involvement WITH either:
5.2.2.1. Gouty tophi present, or
5.2.2.2. Previous joint aspiration confirming the diagnosis of gout, or
5.2.2.3. The presence of hyperuricaemia, or
5.2.2.4. A clinical history of one or more clinical gouty arthritis attack
If none of B1 to B4 is present then we will seek to confirm the diagnosis by visual and microscopic examination of joint aspirate containing crystals.

Although joint aspiration and confirmation of the presence of uric acid crystals is not mandatory for inclusion in this study, nevertheless every patient will be asked whether they will consent to joint aspiration. Records will be kept of those that do and do not agree, and of those patients where aspiration is successful or unsuccessful.

Exclusion Criteria

1. Suspicion of sepsis or other joint disease (e.g. rheumatoid arthritis)
2. Follow up is not possible because of lack of transport or lack of telephone contact
3. Any significant co-morbidity which would interfere with assessment
4. Dementia
5. Confusion
6. Active gastrointestinal symptoms
7. Renal insufficiency with serum creatinine greater than 200 umol/L
8. Bleeding disorder
9. Warfarin
10. Allergy to a study drug
11. Joint aspirate which excluded the diagnosis of gout

It is often not possible to definitively separate gout from septic arthritis on clinical grounds alone, but for this study, sepsis is likely if the patient has a temperature greater than 38°C, chills or rigors, a wound near to the affected joint, a history of immunosuppression, erythematous tracking along a lymphatic vessel or vein in the affected limb, lymphadenopathy, or a previous history of septic arthritis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified