François Rannou, MD, PhD; Jérôme Dimet, PharmD; Isabelle Boutron, MD, PhD; Gabriel Baron, PhD; Fouad Fayad, MD, MS; Yann Macé, MD; Johann Beaudreuil, MD, PhD; Pascal Richette, MD, PhD; Philippe Ravaud, MD, PhD; Michel Revel, MD; Serge Poiraudeau, MD, PhD
Some guidelines recommend splinting for base-of-thumb osteoarthritis, despite lack of evidence of efficacy.
To assess the efficacy and acceptability of a splint for base-of-thumb osteoarthritis.
Multicenter, randomized trial. Randomization was computer-generated, and allocation was concealed by faxing centralized treatment assignment to investigators at the time of enrollment. Patients and investigators were not blinded to assignment, and patients self-reported outcomes.
2 tertiary care hospitals in France.
112 patients (101 women) with base-of-thumb osteoarthritis.
Custom-made neoprene splint (nÂ = 57) or usual care (nÂ = 55).
Primary outcome was change in pain level assessed on a visual analogue scale (VAS) (range, 0 to 100 mm) from baseline to 1 month. Secondary outcomes were change in measures of hand disability at 1 month and change in pain level and measures of disability at 12 months. Tolerance and adherence with the splint were recorded.
At 1 month, no difference in change occurred in pain level from baseline in the intervention and control groups (adjusted mean change, âˆ’10.1 vs. âˆ’10.7; between-group difference, 0.6 [95% CI, âˆ’7.9 to 9.1]; PÂ = 0.89). Disability was assessed by the Cochin Hand Function Scale score (range, 0 to 90) or patient-perceived disability (VAS, 0 to 100 mm). At 12 months, change in pain from baseline was greater in the intervention group than in the control group (adjusted mean change, âˆ’22.2 vs. âˆ’7.9; between-group difference, âˆ’14.3 [CI, âˆ’23.4 to âˆ’5.2]; PÂ = 0.002). The Cochin Hand Function Scale score was âˆ’1.9 versus 4.3 (between-group difference, âˆ’6.3 [CI, âˆ’10.9 to âˆ’1.7]; PÂ = 0.008) and patient-perceived disability was âˆ’11.6 versus 1.5 (between-group difference, âˆ’13.1 [CI, âˆ’21.8 to âˆ’4.4]; PÂ = 0.003). At 12 months, 86% of the intervention group had worn the splint for more than 5 nights a week, and no adverse effects were observed.
Patients, health care providers, and outcome assessors were not blinded.
For patients with base-of-thumb osteoarthritis, wearing a splint had no effect on pain at 1 month but improved pain and disability at 12 months.
Programme Hospitalier de Recherche Clinique National.
Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Macé Y, et al. Splint for Base-of-Thumb Osteoarthritis: A Randomized Trial. Ann Intern Med. 2009;150:661–669. doi: 10.7326/0003-4819-150-10-200905190-00003
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Published: Ann Intern Med. 2009;150(10):661-669.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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