Faculty of Health Sciences, Occupational Therapy Programme, Centre for Rehabilitation & Special Needs Studies, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Occupational Therapy Unit, Hospital Sultan Haji Ahmad Shah, Ministry of Health of Malaysia, Putrajaya, Malaysia.
PLoS One. 2024 Aug 13;19(8):e0307033. doi: 10.1371/journal.pone.0307033. eCollection 2024.
Evidence supports the use of hand-based metacarpophalangeal joint (MCPJ) blocking splints as an intervention for trigger finger (TF). In practice, finger-based relative motion (RM) splints are also implemented without evidence.
This randomized comparative trial (RCT) aims to evaluate implementation of MCPJ blocking and RM splints for effectiveness, function, occupational performance and wearability after 6 weeks of TF management.
Priori analysis determined 36 individuals were needed for random assignment to the RM or MCPJ blocking splint groups. Individuals must be aged ≥21 years, and diagnosed with TF involving ≥1 finger. For blinding purposes, the primary author screens for eligibility, fabricates the splints and educates. Therapist A administers the primary outcome measures Week-1 and Week-6-stage of stenosing tenosynovitis and secondary outcome measures- number of triggering events in 10 active fists, visual analog scales (VAS) for pain, splint comfort and satisfaction, Disabilities of the Arm, Shoulder and Hand, and Canadian Occupational Performance Measure. Therapist B in Week-3 instructs participants in deep tissue massage and administers splint wearability VASs. The RM pencil test is used to determine the affected finger(s) MCPJ splint position i.e., more extension or flexion based on participant response. The MCPJ blocking splint holds the MCPJ in a neutral position. Analysis involves a mixed-effects ANOVA to compare Week-1 and Week-6 primary and secondary outcomes.
Recruitment and data collection are ongoing.
Biomechanically RM splints control tendon excursion and reduce passive tendon tension while allowing unencumbered finger motion and hand function. Hence clinicians use RM splints as an intervention for TF, despite the lack of implementation evidence. This RCT implements a function-focused as well as patient-centered approach with partial blinding of assessors and participants.
We anticipate that this study will provide evidence for the implementation of RM splints to manage adults with TF.
Clinical trial registration This trial is registered with ClinicalTrials.gov (NCT05763017).
有证据支持使用基于手部的掌指关节（MCPJ）阻滞夹板作为扳机指（TF）的干预措施。在实践中，也没有证据支持使用基于手指的相对运动（RM）夹板。
本随机对照试验（RCT）旨在评估 MCPJ 阻滞和 RM 夹板在 TF 管理 6 周后的有效性、功能、职业表现和可穿戴性。
预先分析确定需要 36 名参与者随机分配到 RM 或 MCPJ 阻滞夹板组。参与者必须年满 21 岁，且被诊断为涉及≥1 个手指的 TF。为了实现盲法，主要作者进行资格筛选、制作夹板和教育。治疗师 A 进行主要结局测量（第 1 周和第 6 周狭窄性腱鞘炎阶段）和次要结局测量（10 个主动握拳中的触发事件次数、疼痛的视觉模拟量表（VAS）、夹板舒适度和满意度、上肢功能障碍问卷、加拿大职业表现测量）。治疗师 B 在第 3 周指导参与者进行深部组织按摩并进行夹板可穿戴性 VAS 测量。RM 铅笔测试用于确定受影响手指的 MCPJ 夹板位置，即根据参与者的反应更伸展或更弯曲。MCPJ 阻滞夹板将 MCPJ 保持在中立位置。分析包括混合效应 ANOVA 比较第 1 周和第 6 周的主要和次要结局。
正在进行招募和数据收集。
RM 夹板从生物力学上控制肌腱的运动并降低被动肌腱张力，同时允许手指不受阻碍地运动和手功能。因此，尽管缺乏实施证据，临床医生仍将 RM 夹板作为 TF 的干预措施。本 RCT 采用以功能为重点和以患者为中心的方法，评估者和参与者部分被盲法。
我们预计本研究将为 RM 夹板管理成人 TF 提供实施证据。
本试验在 ClinicalTrials.gov 注册（NCT05763017）。
