Department of Occupational Therapy, Orthopaedic Clinic, Haukeland University Hospital (HUH), Bergen, Norway.
Department for Plastic-, Hand-, Reconstructive surgery and National burn unit, Surgery Clinic, Haukeland University Hospital (HUH), Bergen, Norway.
BMC Musculoskelet Disord. 2019 Aug 28;20(1):387. doi: 10.1186/s12891-019-2712-z.
Dupuytren's contracture (DC) is a fibrotic hand condition in which one or more fingers develop progressive flexion deformities. Quality of life is diminished due to disabling limitations in performing everyday activities. For DC patients treated with collagenase, referral for subsequent hand therapy is inconsistent. It is unknown whether subsequent hand therapy is beneficial compared to no therapy. The purpose of this study is to determine whether hand therapy improves DC patients' performance of and satisfaction with performing everyday activities one year after collagenase treatment.
We will conduct a randomised controlled trial with two treatment groups (hand therapy vs. control) of DC patients who have received collagenase treatment. DC patients with contracted metacarpophalangeal joint(s) (MCPJ) (hand therapy, n = 40; control, n = 40) and those with proximal interphalangeal joint(s) (PIPJ) involvement (hand therapy, n = 40; control, n = 40) comprise two subgroups, and we will study if the treatment effect will be different between both groups (n = 160). Patients with a previous injury or treatment for DC in the treatment finger are excluded. Hand therapy includes oedema and scar management, splinting, movement exercises, and practice of everyday activities. The main outcome variable is patients' performance of and satisfaction with performing everyday activities, as assessed with the Canadian Occupational Performance Measure. Secondary outcomes are DC-specific activity problems, as assessed with the Unité Rhumatologique des Affections de la Main scale, and active/passive flexion/extension of treated joints and grip force using standard measuring tools, and self-reported pain level. Demographic and clinical variables, degree of scarring, cold hypersensitivity, number of occupational sick-leave days are collected. Self-reported global impression of change will be used to assess patient satisfaction with change in hand function. Assessments are done pre-injection and 6 weeks, 4 months, and 1 year later. Standard univariate and multivariate statistical analyses will be used to evaluate group differences.
This study aims to assess whether hand therapy is beneficial for activity-related, biomechanical, and clinical outcomes in DC patients after collagenase treatment. The results will provide an objective basis for determining whether hand therapy should be conducted after collagenase treatment.
This study has been registered at ClinicalTrials.gov as NCT03580213 (April 5, 2018).
掌腱膜挛缩症（Dupuytren's contracture，DC）是一种纤维性手部疾病，其中一个或多个手指会出现进行性弯曲畸形。由于日常生活活动受限，患者的生活质量下降。对于接受胶原酶治疗的 DC 患者，后续手部治疗的转诊并不一致。目前尚不清楚与不治疗相比，后续手部治疗是否有益。本研究旨在确定胶原酶治疗 1 年后，手部治疗是否能提高 DC 患者执行日常活动的能力和对日常活动的满意度。
我们将对接受胶原酶治疗的 DC 患者进行一项随机对照试验，试验有两个治疗组（手部治疗组和对照组）。患有挛缩的掌指关节（metacarpophalangeal joint，MCPJ）（手部治疗组，n=40；对照组，n=40）和近侧指间关节（proximal interphalangeal joint，PIPJ）受累（手部治疗组，n=40；对照组，n=40）的 DC 患者构成两个亚组，我们将研究两组之间的治疗效果是否不同（n=160）。患有治疗手指既往损伤或 DC 治疗史的患者被排除在外。手部治疗包括水肿和瘢痕管理、夹板固定、运动练习和日常活动练习。主要结局变量是患者执行日常活动的能力和对执行日常活动的满意度，使用加拿大职业表现量表进行评估。次要结局变量是 DC 特定活动问题，使用手部关节疾病评定量表进行评估，使用标准测量工具评估治疗关节的主动/被动屈伸活动度和握力，以及自我报告的疼痛水平。收集人口统计学和临床变量、瘢痕程度、冷敏感、职业病假天数。自我报告的总体变化印象用于评估患者对手部功能变化的满意度。评估在注射前、6 周、4 个月和 1 年后进行。将使用标准的单变量和多变量统计分析来评估组间差异。
本研究旨在评估胶原酶治疗后手部治疗对 DC 患者与活动相关的、生物力学的和临床结局的益处。研究结果将为确定胶原酶治疗后是否应进行手部治疗提供客观依据。
本研究已在 ClinicalTrials.gov 注册，编号为 NCT03580213（2018 年 4 月 5 日）。
