Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial

Abstract

BackgroundDupuytren'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.MethodsA 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. 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.Results148 (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.ConclusionsNo 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 registrationThe trial was registered as an International Standard Randomised Controlled Trial ISRCTN57079614

Optimal functional outcome measures for assessing treatment for Dupuytren’s disease: a systematic review and recommendations for future practice

“…Yet, no publication of collagenase injections used PROMs as an outcome and only 15 publications reporting surgical outcomes used function PROMs. Only one RCT reported outcomes using function PROMs [24]. …”

Dupuytren Disease

“…Although postsurgical splinting is often routinely used, its effect on hand mobility and functional status has scarcely been investigated. Two recent articles 19,20 on this topic reported no statistically significant additional value of splinting to hand therapy at 1-year follow-up. Both authors concluded that the policy of splinting all patients after Dupuytren surgery should be reconsidered.…”

Evidence-Based Medicine

“…In a randomized controlled trial of 154 patients undergoing fasciectomy for Dupuytren contracture, Jerosch-Herold et al 36 compared results of therapy alone versus therapy plus nighttime splinting and accounted for variations in compliance with splinting. They found that the routine addition of nighttime splinting for at least 50 percent of nights in the first 3 months after fasciectomy had no overall benefit in range of motion at 1 year after surgery.…”

“…[36][37][38][39][40] Beaudreuil et al addressed this issue by developing the Unité Rhumatologique des Affections de la Main scale, a validated Dupuytren-specific subjective assessment scheme, 41 shown in Table 1. The scale was a final reduction of a list of 52 initial functional questions to the minimum set that statistically correlated best with the Tubiana range-of-motion score and a visual analogue disability score.…”