近指间关节去神经治疗骨关节炎的疗效（DOP）：一项随机对照试验的方案。

Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial.

机构信息

Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Sjukhusbacken 10, Stockholm, 11883, Sweden.

Department for Hand Surgery, Södersjukhuset, Stockholm, Sweden.

出版信息

Trials. 2024 Aug 22;25(1):553. doi: 10.1186/s13063-024-08399-w.

DOI:10.1186/s13063-024-08399-w

PMID:39169395

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11340183/

Abstract

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.

CLINICALTRIALS

gov/ct2/show/NCT05980793 .

摘要

背景

骨关节炎（OA）在全球范围内导致的残疾人数不断增加。对于膝关节和髋关节 OA 的治疗，有大量高质量的研究，但手部 OA 的手术和非手术治疗研究则相对较少。有限的证据表明，教育和锻炼可能会改善手部 OA 的疼痛、功能、僵硬和握力。手部 OA 的既定手术选择存在缺点。假体保留了运动功能，但并发症发生率高，而融合术由于运动受限而降低了功能。手部 OA 的治疗选择需要高质量的研究，需要开发有效且安全的保留运动的治疗方法。本研究旨在比较保留运动的手术治疗（近节指间关节（PIP）关节去神经支配）与患者教育和锻炼计划对疼痛性 PIP OA 患者报告的结果和客观功能的影响。

方法

在这项平行组、双臂、随机、对照优效性试验（RCT）中，将 90 名参与者分配到手术 PIP 关节去神经支配或教育和锻炼组。干预 1 年后的负荷疼痛是主要结局测量指标。次要结局测量指标包括静息疼痛、患者报告的腕关节和手部评估（PRWHE）、HQ8 评分、EQ5D-5L、客观身体功能、并发症、两点辨别觉、Mini Sollerman、镇痛药消耗和进一步手术的需求。评估在基线、3 个月和 6 个月以及干预 1 年后进行。