Treating painful hand osteoarthritis using low dose oral prednisolone- assessing short-term pain and imaging outcomes - POLO

niversity of Leeds0 sitesMay 29, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 29, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Leeds

•1\.Patients must fulfil the American College of Rheumatology criteria for OA of the small joints of the hand (see appendix B).
•2\.Moderately severe symptoms (\=40/100 on hand pain 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 NSAIDs) for at least 4 weeks.
•6\.Stable doses of chondroitin or glucosamine for 4 months.
•7\.No oral, IM, IA, or 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
•Are the trial subjects under 18? no

•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 MRI scanning:
•Pacemakers