Splint for Base-of-Thumb Osteoarthritis

doi:10.1059/0003-4819-150-10-200905190-00003

Splint for Base-of-Thumb Osteoarthritis

A Randomized Trial

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; and
Serge Poiraudeau, MD, PhD

From Assistance Publique–Hôpitaux de Paris, Hôpital Cochin, Hôpital Bichat, and Hôpital Lariboisière; Université Paris Descartes; Université Paris 7 Denis Diderot; Institut National de la Santé et de la Recherche Médicale; and Institut Fédératif de Recherche sur le Handicap, Paris, France, and Unité de Recherche Clinique, Centre Hospitalier Régional, La Roche-sur-Yon, France.

Abstract

Background: Some guidelines recommend splinting for base-of-thumb osteoarthritis, despite lack of evidence of efficacy.

Objective: To assess the efficacy and acceptability of a splint for base-of-thumb osteoarthritis.

Design: 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.

Setting: 2 tertiary care hospitals in France.

Patients: 112 patients (101 women) with base-of-thumb osteoarthritis.

Intervention: Custom-made neoprene splint (n = 57) or usual care (n = 55).

Measurements: 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.

Results: At 1 month, no difference in change occurred in pain level from baseline in the intervention and control groups (adjusted mean change, −10.1 vs. −10.7; between-group difference, 0.6 [95% CI, −7.9 to 9.1]; P = 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, −22.2 vs. −7.9; between-group difference, −14.3 [CI, −23.4 to −5.2]; P = 0.002). The Cochin Hand Function Scale score was −1.9 versus 4.3 (between-group difference, −6.3 [CI, −10.9 to −1.7]; P = 0.008) and patient-perceived disability was −11.6 versus 1.5 (between-group difference, −13.1 [CI, −21.8 to −4.4]; P = 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.

Limitation: Patients, health care providers, and outcome assessors were not blinded.

Conclusion: 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.

Primary Funding Source: Programme Hospitalier de Recherche Clinique National.

Article and Author Information

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, serge.poiraudeau{at}cch.aphp.fr).
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, serge.poiraudeau{at}cch.aphp.fr.
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.