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

ISRCTN ISRCTN99697616
DOI https://doi.org/10.1186/ISRCTN99697616
Protocol serial number RR09/8877
Sponsor University of Leeds (UK)
Funder University of Leeds (UK)
Submission date
18/11/2010
Registration date
09/05/2011
Last edited
10/09/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Philip G Conaghan
Scientific

Section of Musculoskeletal Disease
Second Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom

p.conaghan@leeds.ac.uk

Study information

Primary study designInterventional
Study designRandomised placebo-controlled double-blind single centre study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleTreating 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
Study acronymPOLO
Study objectivesCurrent treatments for osteoarthritis (OA) have major limitations and other analgesic treatments are needed. Synovitis is prevalent in OA and previous studies have shown it to be a source of pain. Corticosteroids are used in routine practice at treating synovitis in both the inflammatory arthritides and in osteoarthritis and have been shown to be effective at reducing pain.

We propose that treating patients with moderate to severe OA hand symptoms with low dose oral prednisolone will be a practical and safe treatment to reduce synovitis and therefore reduce pain. This will potentially introduce a new treatment into the OA armamentarium which could be of particular use in the primary care setting.
Ethics approval(s)Leeds (West) Research Ethics Committee approved on the 22nd May 2009 (ref: 09/H1307/53)
Health condition(s) or problem(s) studiedPainful hand osteoarthritis
InterventionPatients 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 total trial duration will be 12 weeks; 4 weeks of treatment then a follow-up visit 8 weeks later.
Intervention typeDrug
PhasePhase IV
Drug / device / biological / vaccine name(s)Prednisolone
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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.

Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration70
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment17/08/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Section of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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