A randomized, double-blind, placebo-controlled trial of low-dose oral prednisolone for treating painful hand osteoarthritis

Rheumatology (Oxford). 2012 Dec;51(12):2286-94. doi: 10.1093/rheumatology/kes219. Epub 2012 Sep 6.

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.

Conclusion: 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.

Trial registration: International Standard Randomised Controlled Trial Number Register, www.isrctn.org, Trial number 99697616.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Analgesics / administration & dosage*
  • Analysis of Variance
  • Anti-Inflammatory Agents / administration & dosage*
  • Capsules
  • Double-Blind Method
  • Female
  • Hand
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Musculoskeletal Pain / prevention & control*
  • Osteoarthritis / complications
  • Osteoarthritis / drug therapy*
  • Osteoarthritis / pathology
  • Pain Measurement
  • Prednisolone / administration & dosage*
  • Synovitis / pathology
  • Treatment Outcome

Substances

  • Analgesics
  • Anti-Inflammatory Agents
  • Capsules
  • Prednisolone