掌指关节炎关节内注射肉毒毒素 A 的随机试验方案（RHIBOT）

Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT).

机构信息

AP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.

Unité de Recherche Clinique - Centre d'Investigation Clinique Paris Descartes Necker/Cochin, Hôpital Tarnier, Paris, France.

出版信息

BMJ Open. 2018 Jun 30;8(6):e022337. doi: 10.1136/bmjopen-2018-022337.

DOI:10.1136/bmjopen-2018-022337

PMID:29961037

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6042589/

Abstract

INTRODUCTION

Recent studies have suggested that intra-articular injection of botulinum toxin A (BTA) may have analgesic effects in degenerative joint diseases. We aim to assess the efficacy of intra-articular injection of BTA associated with splinting in patients with trapeziometacarpal osteoarthritis (TMC OA).

METHODS AND ANALYSIS

We will conduct a randomised double-blind controlled trial. Overall, 60 individuals with TMC OA fulfilling adapted 1990 American College of Rheumatology criteria for hand OA will be recruited in one tertiary care centre in France and randomised to receive splinting + a single ultrasound-guided injection in the TMC joint of 50 Allergan Units of BTA resuspended in 1 mL saline or splinting +1 mL saline. Randomisation will be centralised. The allocation ratio will be 1:1. The primary outcome will be the mean change from baseline in base-of-thumb pain on a self-administered 11-point Numeric Rating Scale in 10-point increments at 3 months after injection. Secondary outcomes will be the mean change in base-of-thumb pain at 1 and 6 months, mean change in hand-specific activity limitations assessed by the self-administered Cochin Hand Function Scale, proportion of responders assessed by the Osteoarthritis Research Society International -Outcome Measures in Rheumatology (OMERACT) criteria and consumption of analgesics and non-steroidal anti-inflammatory drugs assessed by a self-administered 4-class scale at 3 and 6 months. Cointerventions will be allowed in both groups and will be self-reported. Adverse events will be recorded at 3 and 6 months. Participants, care providers and statisticians will be blinded to the allocated treatment.

ETHICS AND DISSEMINATION

The RHIBOT trial has been authorised by the Agence Nationale de Sécurité du Médicament and approved by the Comité de Protection des Personnes de Tours Ouest-1. The findings of the study will be disseminated in peer-reviewed journals and at conferences. If the results are positive, intra-articular BTA could be an efficient and safe complementary therapeutic option for patients with TMC OA.

DATE AND VERSION IDENTIFIER OF THE PROTOCOL

8 January 2018, V. 2.0.

TRIAL REGISTRATION NUMBER

NCT03187626; Pre-results.

摘要

简介

最近的研究表明，关节内注射肉毒杆菌毒素 A（BTA）可能在退行性关节疾病中具有镇痛作用。我们旨在评估关节内注射 BTA 联合夹板固定治疗腕掌关节骨关节炎（TMC OA）患者的疗效。

方法和分析

我们将进行一项随机双盲对照试验。总体而言，将在法国的一个三级保健中心招募 60 名符合改良的 1990 年美国风湿病学会手部 OA 标准的 TMC OA 患者，并将其随机分为两组，分别接受夹板固定+超声引导下 TMC 关节内注射 50 单位的 Allergan 单位 BTA 重悬于 1 mL 盐水中或夹板固定+1 mL 生理盐水。随机分组将采用中心化方式进行。分配比例为 1:1。主要结局指标为注射后 3 个月时自我管理的 11 分制数字评分量表（NRS）在 10 分增量上拇指基底部疼痛的平均变化。次要结局指标包括拇指基底部疼痛在 1 个月和 6 个月时的平均变化、自我管理的 Cochin 手部功能量表评估的手部特定活动受限的平均变化、根据骨关节炎研究协会国际 - 风湿病结局测量（OMERACT）标准评估的反应者比例以及自我管理的 4 级量表在 3 个月和 6 个月时评估的镇痛药和非甾体抗炎药的消耗。两组均允许联合治疗，且均为自我报告。不良事件将在 3 个月和 6 个月时记录。参与者、护理提供者和统计人员将对分配的治疗方案设盲。