Abstract | OBJECTIVE: 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.
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Authors | Claire Y J Wenham, Elizabeth M A Hensor, Andrew J Grainger, Richard Hodgson, Sharon Balamoody, Caroline J Doré, Paul Emery, Philip G Conaghan |
Journal | Rheumatology (Oxford, England)
(Rheumatology (Oxford))
Vol. 51
Issue 12
Pg. 2286-94
(Dec 2012)
ISSN: 1462-0332 [Electronic] England |
PMID | 22956551
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics
- Anti-Inflammatory Agents
- Capsules
- Prednisolone
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Topics |
- 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, drug therapy, pathology)
- Pain Measurement
- Prednisolone
(administration & dosage)
- Synovitis
(pathology)
- Treatment Outcome
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