Contact information
Type
Scientific
Primary contact
Prof Philip G Conaghan
ORCID ID
Contact details
Section of Musculoskeletal Disease
Second Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
p.conaghan@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RR09/8877
Study information
Scientific title
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
Acronym
POLO
Study hypothesis
Current 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
Leeds (West) Research Ethics Committee approved on the 22nd May 2009 (ref: 09/H1307/53)
Study design
Randomised placebo-controlled double-blind single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact c.y.j.wenham@leeds.ac.uk to request a patient information sheet
Condition
Painful hand osteoarthritis
Intervention
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 total trial duration will be 12 weeks; 4 weeks of treatment then a follow-up visit 8 weeks later.
Intervention type
Drug
Phase
Phase IV
Drug names
Prednisolone
Primary outcome measure
Change in hand pain VAS, measured from 0 mm (no pain) to 100 mm (severe pain) from baseline to 4 weeks
Secondary outcome measures
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.
Overall trial start date
17/08/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant 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
Recruitment start date
17/08/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Dr Neville Young
QA Office
c/o Research and Development Office
34 Hyde Terrace
Leeds
LS9 6LN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Leeds (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22956551
Publication citations
-
Results
Wenham CY, Hensor EM, Grainger AJ, Hodgson R, Balamoody S, Doré CJ, Emery P, Conaghan PG, A randomized, double-blind, placebo-controlled trial of low-dose oral prednisolone for treating painful hand osteoarthritis., Rheumatology (Oxford), 2012, 51, 12, 2286-2294, doi: 10.1093/rheumatology/kes219.