背景:骨关节炎(OA)在全球范围内越来越多地导致残疾。关于膝关节和髋关节OA的治疗有大量高质量的研究,而手OA手术和非手术治疗的研究很少。有限的证据表明,教育和锻炼可以改善疼痛,函数,刚度,手OA的握力。在手OA中建立的手术选择具有缺点。假体保持运动,但并发症发生率高,而融合由于有限的运动而降低功能。对于手部OA的治疗选择的高质量研究存在未满足的需求,并且需要开发有效且安全的运动保护疗法。这项研究旨在比较保留运动的手术治疗(近端指间(PIP)关节的神经支配)与患者教育和锻炼计划对疼痛的PIPOA患者报告的结果和目标功能的影响。
方法:在这个平行组中,双臂,随机化,对照优势试验(RCT),90名参与者被分配到手术PIP关节去神经或教育和锻炼。干预后1年的负重疼痛是主要结果指标。次要结果指标包括休息时的疼痛,患者额定腕部和手部评估(PRWHE),HQ8得分,EQ5D-5L,客观物理功能,并发症,两点歧视,迷你Sollerman,镇痛药的消耗,以及进一步手术的需要。评估在基线进行,3和6个月,干预后1年。
结论:以前没有RCT比较PIPOA的手术和非手术治疗。如果患者教育加运动或PIP去神经支配改善功能,这些治疗可作为PIPOA的一线治疗方案.然而,如果去神经支配没有取得比非手术治疗更好的效果,在PIPOA中使用是不合理的。
背景:于2023年8月8日在ClinicalTrials.gov(NCT05980793)中进行了前瞻性注册。URLhttps://classic。
结果:gov/ct2/show/NCT05980793。
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.
CONCLUSIONS: 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.
BACKGROUND: Prospectively registered in ClinicalTrials.gov (NCT05980793) on 8 August 2023. URL https://classic.
RESULTS: gov/ct2/show/NCT05980793 .