Treating painful hand osteoarthritis using low dose oral prednisolone: assessing short-term pain and imaging outcomes in a randomised, placebo-controlled, double-blind, 12 week, single centre study

niversity of Leeds (UK)0 sites70 target enrollmentMay 9, 2011

Overview

No summary available.

Registry

who.int

Start Date

May 9, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds (UK)

•1\. Patients must fulfil the American College of Rheumatology criteria for OA of the small joints of the hand
•2\. Moderately severe symptoms (greater than or equal to 40/100 on hand pain visual analogue scale \[VAS] at screening)
•3\. Symptoms present on most days over the last 3 months
•4\. A previous radiograph of the hands with changes consistent with osteoarthritis
•5\. Stable analgesic requirements (including non\-steriodal anti\-inflammatory drugs \[NSAIDs]) for at least 4 weeks
•6\. Stable doses of chondroitin or glucosamine for 4 months
•7\. No oral, intramuscular \[IM], intra\-arterial \[IA], or intravenous \[IV] steroids during the last 3 months
•8\. The patient must be able to adhere to the study visit schedule and other protocol requirements
•9\. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
•10\. Aged 43 \- 81 years, either sex

•1\. The presence of an inflammatory arthritis
•2\. Sensitivity, anaphylaxis or allergy to prednisolone
•3\. Patients who are pregnant, lactating or using hormonal birth control pills
•4\. Currently uncontrolled diabetes
•5\. Currently uncontrolled hypertension
•6\. Current active infection
•7\. Surgical procedure within 30 days of study initiation
•8\. Patients with osteoporosis or taking bisphosphonates
•9\. Patients will not be eligible if they have any contraindications to magnetic resonance imaging (MRI) scanning:
•9\.1\. Pacemakers