Condition category
Musculoskeletal Diseases
Date applied
18/11/2010
Date assigned
09/05/2011
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.leedsth.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22956551

Publication citations

  1. 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.

Additional files

Editorial Notes