Abstract
Background Dupuytren’s disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function. Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting; however the evidence supporting night splinting is of low quality and equivocal.Methods A multi-centre, pragmatic, open, randomised controlled trial was conducted to evaluate the effect of night splinting on self-reported function, finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy. A total of 154 patients from 5 regional hospitals were randomised after surgery to receive hand therapy only (n = 77) or hand therapy with night splinting (n = 77). Primary outcome was self-reported function using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcomes were finger range of motion and patient satisfaction. Primary analysis was by intention to treat.Results A total of 148 (96%) patients completed follow-up at 12 months. No statistically significant differences were observed on the DASH questionnaire (0–100 scale: adjusted mean diff. 0.66, 95%CI −2.79 to 4.11, p = 0.703), total extension deficit of operated digits (degrees: adjusted mean diff 5.11, 95%CI −2.33 to 12.55, p = 0.172) or patient satisfaction (0–10 numerical rating scale: adjusted mean diff −0.35, 95%CI −1.04 to 0.34, p = 0.315) at 1 year post surgery. Similarly, in a secondary per-protocol analysis, no statistically significant differences were observed between the groups in any of the outcomes.Conclusions No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred. Given the added expense of therapists’ time, thermoplastic materials and the potential inconvenience to patients having to wear a device, the routine addition of night-time splinting for all patients after fasciectomy or dermofasciectomy is not recommended except where extension deficits reoccur.Trial Registration The trial was registered as an International Standard Randomised Controlled Trial ISRCTN57.7.6.4.41.1
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Competing Interests
The authors declare that they have no competing interests.
Authors’ Contributions
CJH, LS, AJC and DL all contributed to the trial concept and design, interpretation of data and drafting of the manuscript. LS undertook the statistical analysis. EB and SV conducted all data collection. CJH, LS, AJC and DL obtained funding. All authors revised the manuscript for important intellectual content and have read and approved the final version.
Acknowledgements
Action Medical Research Charity funded the trial costs including all consumables and research associate salaries (AP1074). CJH and LS were funded by the Faculty of Health, University of East Anglia. The National Institute for Health Research (NIHR) funded CJH through a Career Development Fellowship from January 2009. The study received support by NIHR through the Comprehensive Local Research Network.
The SCoRD Trial Group included:
Investigators: C Jerosch-Herold, L Shepstone, A Chojnowski, D Larson.
Surgeons and sites: P Chapman, A Chojnowski, A Logan, M Meyer, A Patel (Norwich); G Cormack, J Hopkinson-Woolley, I Grant (Cambridge); M Wood (Bury St Edmunds); J Jones, A White, A Doran (Peterborough); P Crossman, C Roberts, M Shanahan (Ipswich). Lead Hand Therapists and sites: D Larson (Norwich), M Hayden (Cambridge); Laura Smith (Bury St Edmunds); Jill Frusher (Peterborough), J Dinley (Ipswich). Trial research staff: E Barrett, S Vaughan. Independent Trial Steering Committee members: DGI Scott, S Spooner. Local PPIRes members: C Handford, V Hawes, C Williams.
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This chapter has been published first in BMC Musculoskeletal Disorders 2011, 12:136doi:10.1186/1471-2474-12-136. It is re-printed in a slightly modified form and with permission by the authors.
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Jerosch-Herold, C., Shepstone, L., Chojnowski, A.J., Larson, D., Barrett, E., Vaughan, S.P. (2012). Night-Time Splinting After Fasciectomy or Dermofasciectomy for Dupuytren’s Contracture: A Pragmatic, Multi-centre, Randomised Controlled Trial. In: Eaton, C., Seegenschmiedt, M., Bayat, A., Gabbiani, G., Werker, P., Wach, W. (eds) Dupuytren’s Disease and Related Hyperproliferative Disorders. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-22697-7_41
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