Painful hand osteoarthritis Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
Patients will be randomised to either one of the following regimens:
1. One capsule containing 5 miligrams of prednisolone daily for 28 days orally
2. Placebo capsule one daily for 28 days orally
The
4 weeks of treatment then a follow-up visit 8 weeks later.
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 9.2. Surgical clips within the head 9.3. Certain inner ear implants 9.4. Neuro-electrical stimulators 9.5. Metal fragments within the eye or head 9.6. Pregnant or breastfeeding women 10. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer 11. Subjects with any uncontrolled, unstable or severe medical condition, which in the opinion of the investigator makes them unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hand pain VAS, measured from 0 mm (no pain) to 100 mm (severe pain) from baseline to 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in functional scores (including the Australian/Canadian Osteoarthritis Hand Index [AUSCAN] functional subscale) at 4 and 12 weeks. Measured using the VAS AUSCAN 0 - 100 mm whereby 0 mm = no difficulty and 100 mm = extreme difficulty 2. Change in pain scores (including VAS global disease activity score and AUSCAN pain subscale) at 4 and 12 weeks. Disease activity scores are measured from 0 mm (no activity) to 100 mm (extreme activity). Pain scores are measured from 0 mm (no pain) to 100 mm (extreme pain). 3. Change in Osteoarthritis Quality of Life questionnaire (OAQoL) scores at 12 weeks 4. Change in Hospital Anxiety and Depression Scale (HADS) scores at 4 and 12 weeks 5. Changes on extremity MRI scan at baseline and 4 weeks. MRIs will be scored for synovitis using a semi-quantitative scoring system. | — |
Countries
United Kingdom
Outcome results
None listed