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
Acknowledgment: Laura Heraty participated as a medical editor in the elaboration of the final version of the manuscript.
Grant Support: By the Programme Hospitalier de Recherche Clinique National (PHRC AOM grant 02038).
Potential Financial Conflicts of Interest: None disclosed.
Reproducible Research Statement:Study protocol, statistical code, and data set: Available (in French) from Dr. Poiraudeau (e-mail, email@example.com).
Requests for Single Reprints: Serge Poiraudeau, MD, PhD, Service de Médecine Physique et Réadaptation, Hôpital Cochin, 27 Rue du Faubourg Saint Jacques, 75679 Paris Cedex 14, France; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Rannou, Dimet, Boutron, Baron, Fayad, Macé, Beaudreuil, Richette, Ravaud, Revel, and Poiraudeau: Service de Médecine Physique et Réadaptation, Hôpital Cochin, 27 Rue du Faubourg Saint Jacques, 75679 Paris Cedex 14, France.
Author Contributions: Conception and design: F. Rannou, I. Boutron, P. Ravaud, M. Revel, S. Poiraudeau.
Analysis and interpretation of the data: F. Rannou, J. Dimet, I. Boutron, G. Baron, P. Ravaud, S. Poiraudeau.
Drafting of the article: F. Rannou, S. Poiraudeau.
Critical revision of the article for important intellectual content: F. Rannou, J. Dimet, I. Boutron, G. Baron, F. Fayad, Y. Macé, J. Beaudreuil, P. Richette, P. Ravaud, M. Revel, S. Poiraudeau.
Final approval of the article: F. Rannou, J. Dimet, I. Boutron, G. Baron, F. Fayad, Y. Macé, J. Beaudreuil, P. Richette, P. Ravaud, M. Revel, S. Poiraudeau.
Provision of study materials or patients: F. Rannou, F. Fayad, Y. Macé, J. Beaudreuil, P. Richette, M. Revel, S. Poiraudeau.
Statistical expertise: J. Dimet, I. Boutron, G. Baron, P. Ravaud.
Obtaining of funding: S. Poiraudeau.
Administrative, technical, or logistic support: J. Dimet, S. Poiraudeau.
Collection and assembly of data: F. Rannou, F. Fayad, Y. Macé, J. Beaudreuil, P. Richette.
ClinicalTrials.gov registration number: NCT00350896.
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.
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.
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