Elin M Swärd, Jonas Beckman, Farnoush Tabaroj, Maria K Wilcke
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This study aims to compare the effects of a motion-preserving surgical treatment (denervation of the proximal interphalangeal (PIP) joint) with a patient education and exercise program on patient-reported outcomes and objective function in painful PIP OA.</p><p><strong>Methods: </strong>In this parallel-group, two-armed, randomized, controlled superiority trial (RCT), 90 participants are assigned to surgical PIP joint denervation or education and exercise. Pain on load 1 year after intervention is the primary outcome measure. Secondary outcome measures include pain at rest, Patient-Rated Wrist and Hand Evaluation (PRWHE), HQ8 score, EQ5D-5L, objective physical function, complications, two-point discrimination, Mini Sollerman, consumption of analgesics, and the need for further surgery. 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引用次数: 0
摘要
背景：骨关节炎（OA）越来越多地导致全球范围内的残疾。有关膝关节和髋关节 OA 治疗的高质量研究很多，但有关手部 OA 手术和非手术治疗的研究却很少。有限的证据表明，教育和锻炼可以改善手部OA的疼痛、功能、僵硬和握力。治疗手部 OA 的既有手术方案也有缺点。假肢可以保持活动，但并发症发生率较高，而融合术则会因活动受限而降低功能。对手部 OA 治疗方案进行高质量研究的需求尚未得到满足，因此需要开发有效、安全的保护运动疗法。本研究旨在比较保留运动的手术治疗（近端指间关节（PIP）神经支配）与患者教育和锻炼计划对疼痛性 PIP OA 患者报告结果和客观功能的影响：在这项平行分组、双臂随机对照优效试验（RCT）中，90名参与者被分配接受PIP关节去神经化手术或教育和锻炼。干预1年后负重时的疼痛是主要的结果测量指标。次要结果指标包括静息时的疼痛、患者评定的腕部和手部评估（PRWHE）、HQ8 评分、EQ5D-5L、客观身体功能、并发症、两点辨别力、Mini Sollerman、止痛药消耗量以及是否需要进一步手术。评估在基线、3个月和6个月以及干预后1年进行：讨论：目前还没有任何一项研究对PIP OA的手术治疗和非手术治疗进行比较。如果患者教育加锻炼或腓骨神经支配能改善患者的功能，那么这些治疗方法可作为腓骨骨性关节炎的一线治疗方案。但是，如果去神经化治疗不能取得比非手术治疗更好的效果，那么就没有理由将其用于PIP OA：试验注册：2023年8月8日在ClinicalTrials.gov（NCT05980793）进行了前瞻性注册。URL https://classic.Clinicaltrials: gov/ct2/show/NCT05980793 。
Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial.
Background: Osteoarthritis (OA) contributes increasingly to disability worldwide. There is ample high-quality research on the treatment of knee and hip OA, whereas research on surgical and non-surgical treatment in hand OA is sparse. Limited evidence suggests that education and exercise may improve pain, function, stiffness, and grip strength in hand OA. The established surgical options in hand OA have disadvantages. Prostheses preserve motion but have a high complication rate, whereas fusions decrease function due to limited movement. There is an unmet need for high-quality research on treatment options for hand OA and a need for the development of effective and safe movement-sparing therapies. This study aims to compare the effects of a motion-preserving surgical treatment (denervation of the proximal interphalangeal (PIP) joint) with a patient education and exercise program on patient-reported outcomes and objective function in painful PIP OA.
Methods: In this parallel-group, two-armed, randomized, controlled superiority trial (RCT), 90 participants are assigned to surgical PIP joint denervation or education and exercise. Pain on load 1 year after intervention is the primary outcome measure. Secondary outcome measures include pain at rest, Patient-Rated Wrist and Hand Evaluation (PRWHE), HQ8 score, EQ5D-5L, objective physical function, complications, two-point discrimination, Mini Sollerman, consumption of analgesics, and the need for further surgery. Assessments are performed at baseline, 3 and 6 months, and 1 year after intervention.
Discussion: There are no previous RCTs comparing surgical and non-surgical treatment in PIP OA. If patient education plus exercise or PIP denervation improve function, these treatments could be implemented as first-line treatment options in PIP OA. However, if denervation does not achieve better results than non-surgical treatment, it is not justified to use in PIP OA.
Trial registration: Prospectively registered in ClinicalTrials.gov (NCT05980793) on 8 August 2023. URL https://classic.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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