A short course of low dose steroid tablets as a treatment for painful hand osteoarthritis- does it work?

Completed

Conditions: Painful hand osteoarthritis
Musculoskeletal Diseases
Osteoarthritis

Registration Number: ISRCTN99697616

Lead Sponsor: niversity of Leeds (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in hand pain VAS, measured from 0 mm (no pain) to 100 mm (severe pain) from baseline to 4 weeks

Secondary Outcome Measures

Name	Time	Method
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<br>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).<br>3. Change in Osteoarthritis Quality of Life questionnaire (OAQoL) scores at 12 weeks<br>4. Change in Hospital Anxiety and Depression Scale (HADS) scores at 4 and 12 weeks<br>5. Changes on extremity MRI scan at baseline and 4 weeks. MRIs will be scored for synovitis using a semi-quantitative scoring system.