Background/Purpose: Pain is a major symptom in hand osteoarthritis (OA), with many patients taking analgesics including acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs) and even opioids. Patients with OA who do not respond to conventional analgesics may have ‘sensitization’, or heightened pain symptoms which are centrally mediated. We hypothesized that patients with hand OA who have features of sensitization may improve with centrally-acting analgesics including duloxetine or pregabalin.

Methods:   A prospective, randomized, double-blind, placebo-controlled trial from 42 primary care and rheumatology clinics in the UK. We recruited 85 participants: 65 with hand OA confirmed by ACR criteria (mean age 62 years) and 20 age-matched non-OA controls. Patients were assigned 1:1:1 to treatment with duloxetine (up to 60 mg), pregabalin (up to 300 mg) or matched placebo. The primary endpoints were the Australian and Canadian Hand Osteoarthritis Index (AUSCAN) pain score change and the Visual Analogue Scale (VAS) pain rating 0-10 from baseline to 12 weeks treatment. Secondary endpoints were AUSCAN function, Hospital Anxiety and Depression Scale (HADS) and pain pressure thresholds (PPTs) for sensitization measured by algometry (Wagner).

Results:   All participants were randomised and included in the intention-to-treat analysis. The highest mean reduction in AUSCAN pain scores was achieved for the pregabalin group (mean change -132.1, 95% confidence interval -181.1 to -82.9) followed by duloxetine (mean change -62.5, 95% confidence interval -141.6 to 16.6) and placebo (mean change -47.1, 95% confidence interval -93.9 to 11.7). The most significant improvement after treatment was in the pregabalin group compared with placebo (p=0.013), Figure 1. AUSCAN pain reduction for duloxetine was not significant (p=0.90). VAS pain outcome was significant for pregabalin (p<0.00001) and duloxetine (p=0.029) respectively with no change in depression or anxiety scores in any group. PPT were lower in hand OA than non-OA controls at baseline (p<0.05). Side effects were similar in pregabalin and duloxetine groups, although more neurological side effects occurred in the pregabalin group including dizziness, dry mouth, sleepiness and loss of balance. PPT were useful for screening for sensitization, but did not change significantly after treatment (p>0.05).

Conclusion:   Pregabalin has significant efficacy at 300 mg in improving pain and function after 12 weeks compared with duloxetine or placebo in hand OA. VAS pain outcomes for pregabalin and duloxetine both showed significant efficacy over placebo. PPTs are useful for screening for sensitization and identifying participants who are likely to respond to centrally-acting analgesics. Our results demonstrate evidence for pregabalin as an alternative for OA pain in sensitized patients and clinical trials that examine the balance between efficacy and side effects should be encouraged.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pregabalin-is-more-effective-in-treating-hand-osteoarthritis-pain-than-duloxetine-or-placebo-a-double-blind-randomized-controlled-trial/