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 |
| Secondary identifying numbers | RR09/8877 |
- 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
Scientific
Section of Musculoskeletal Disease
Second Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
| p.conaghan@leeds.ac.uk |
Study information
| Study design | Randomised placebo-controlled double-blind single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact c.y.j.wenham@leeds.ac.uk to request a patient information sheet |
| 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 |
| Study acronym | POLO |
| Study objectives | 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(s) | Leeds (West) Research Ethics Committee approved on the 22nd May 2009 (ref: 09/H1307/53) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 17/08/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/08/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Dr Neville Young
QA Office
c/o Research and Development Office
34 Hyde Terrace
Leeds
LS9 6LN
England
United Kingdom
| Website | http://www.leedsth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
University/education
University of Leeds (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
