title: A randomized, double-blind, placebo-controlled trial of low-dose oral prednisolone for treating painful hand osteoarthritis.
abstract: OBJECTIVE
  Anti-inflammatory therapies are effective analgesics for OA. This study determined whether low-dose oral prednisolone (PNL) was an effective analgesic for hand OA.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled trial of people with ACR criteria hand OA and baseline hand pain visual analogue scale (VAS) of >40/100 mm. Participants received 5 mg PNL or placebo daily for 4 weeks. Pain VAS, disease activity VAS, Australian/Canadian Hand Osteoarthritis Index and joint counts were performed at baseline, 4 and 12 weeks. Primary outcome was the change in hand pain VAS at 4 weeks. Analysis of covariance was used for analysis, controlling for baseline values. To explore potential mechanism of action of PNL, non-contrast 0.2 Tesla MRI was performed on the most painful hand at baseline and 4 weeks.
  
  
  RESULTS
  A total of 70 participants were recruited (57 women, mean age 61 years, mean baseline pain VAS 61.5 mm); 75% had more than one joint with definite MRI synovitis/effusion. At 4 weeks the adjusted mean reduction in pain VAS was 19.9 mm (PNL group) and 16.8 mm (placebo group) (P = 0.54). There were no statistically significant differences in VAS, Australian/Canadian Hand Osteoarthritis Index or joint counts between placebo and PNL groups at 4 or 12 weeks. A total of 20 participants in each group achieved an Outcome Measures in Rheumatology-Osteoarthritis Research Society International response. Baseline synovitis/effusion did not predict response to treatment.
  
  
  CONCLUSIONS
  This is the first randomized controlled trial of low-dose corticosteroid alone for painful hand OA, which demonstrated that short-term low-dose oral PNL is not an effective analgesic treatment for hand OA.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number Register, www.isrctn.org, Trial number 99697616.
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK.
authors.forename: Claire Y J
authors.initials: CY
authors.lastname: Wenham
authors.forename: Elizabeth M A
authors.initials: EM
authors.lastname: Hensor
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Grainger
authors.forename: Richard
authors.initials: R
authors.lastname: Hodgson
authors.forename: Sharon
authors.initials: S
authors.lastname: Balamoody
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Doré
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage*; D000704:Analysis of Variance; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002214:Capsules; D004311:Double-Blind Method; D005260:Female; D006225:Hand; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D059352:Musculoskeletal Pain / Q000517:prevention & control*; D010003:Osteoarthritis / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D010147:Pain Measurement; D011239:Prednisolone / Q000008:administration & dosage*; D013585:Synovitis / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000893:Anti-Inflammatory Agents; D002214:Capsules; D011239:Prednisolone