Faculty of Medicine and Health Sciences, University of East Anglia, Norwich NR4 7TJ, UK.
BMC Musculoskelet Disord. 2011 Jun 21;12:136. doi: 10.1186/1471-2474-12-136.
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.
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. 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.
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.
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.
The trial was registered as an International Standard Randomised Controlled Trial ISRCTN57079614.
掌腱膜挛缩症是一种进行性纤维增生性疾病，可导致手指固定性屈曲挛缩和手部功能受损。标准治疗包括手术松解或切除，然后进行术后手部治疗和夹板固定，但夜间夹板固定的证据质量低且存在争议。
进行了一项多中心、实用、开放、随机对照试验，以评估掌腱膜挛缩症患者接受筋膜切开术或皮筋切开术后夜间夹板固定对自我报告功能、手指伸展和满意度的影响。 5 家地区医院的 154 名患者在手术后随机分为仅接受手部治疗（n = 77）或手部治疗加夜间夹板固定（n = 77）。主要结局是使用残疾上肢、肩和手（DASH）问卷报告的自我报告功能。次要结局是手指活动范围和患者满意度。主要分析是意向治疗。
148 名（96%）患者在 12 个月时完成了随访。在 DASH 问卷上未观察到统计学显著差异（0-100 量表：调整后的平均差异 0.66，95%CI-2.79 至 4.11，p = 0.703）、手术手指总伸展不足（度：调整后的平均差异 5.11，95%CI-2.33 至 12.55，p = 0.172）或患者满意度（0-10 数字评分量表：调整后的平均差异-0.35，95%CI-1.04 至 0.34，p = 0.315）在手术后 1 年。同样，在二次按方案分析中，两组在任何结局中均未观察到统计学显著差异。
在接受常规手术后夹板固定的一组患者和仅在出现挛缩时接受手部治疗和夹板固定的一组患者之间，自我报告的上肢残疾或主动活动范围没有观察到差异。考虑到治疗师时间、热塑性材料的额外费用以及患者佩戴设备的潜在不便，如果术后出现伸展不足，除了再次出现伸展不足外，不建议常规在所有接受筋膜切开术或皮筋切开术的患者中添加夜间夹板固定。
该试验作为国际标准随机对照试验 ISRCTN57079614 进行注册。
