Li Duo Yi, Han Rong, Zhao Zhi Gang, Luo Fang
Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
BMJ Open. 2020 Oct 27;10(10):e036447. doi: 10.1136/bmjopen-2019-036447.
Intra-articular (IA) injection of hyaluronic acid (HA) and corticosteroid (CS) is a common treatment for osteoarthritis (OA) of the knee. As a drug treatment for patients with depression, duloxetine has been shown in many studies to effectively relieve the pain of OA and improve function of the knee joint. However, evidence regarding the efficacy of IA injection of HA+CS combined with duloxetine for pain management in patients with OA of the knee is lacking. The aim of this study was to test the hypothesis that IA injection of HA+CS combined with duloxetine could achieve pain management superior to that of IA injection of HA+CS alone in patients experiencing knee OA pain.
This study will adopt a prospective, randomised, open-label blind endpoint study design. In total, 150 patients with OA of the knee will be enrolled in the study. The participants will be randomly allocated to receive either a single IA injection of HA+CS combined with duloxetine or a single IA injection of HA+CS alone, and both groups will complete a 24-week follow-up to assess pain and functional improvements. The primary outcome measure is the change in the weekly mean of the 24 hours average pain scores from baseline to the end of 24 weeks in patients with OA of the knee, and the secondary outcomes include the response to treatment, changes from baseline in the brief pain inventory, improvement in the Western Ontario and McMaster Universities Osteoarthritis index scores, patient global impression of improvement scale, Hospital Anxiety and Depression Scale and adverse events during the 24-week follow-up. The data will be analysed by the intention-to-treat principle.
This study was approved by the institutional ethics committee of the Beijing Tiantan Hospital (approval number: KY 2019-086-02). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
ClinicalTrials.gov Identifier: NCT04117893; Pre-results.
关节腔内（IA）注射透明质酸（HA）和皮质类固醇（CS）是膝关节骨关节炎（OA）的常见治疗方法。作为抑郁症患者的药物治疗，度洛西汀在许多研究中已显示能有效缓解OA疼痛并改善膝关节功能。然而，关于IA注射HA + CS联合度洛西汀用于膝关节OA患者疼痛管理疗效的证据尚缺乏。本研究的目的是检验以下假设：在经历膝关节OA疼痛的患者中，IA注射HA + CS联合度洛西汀在疼痛管理方面优于单独IA注射HA + CS。
本研究将采用前瞻性、随机、开放标签盲终点研究设计。总共150例膝关节OA患者将纳入本研究。参与者将被随机分配接受单次IA注射HA + CS联合度洛西汀或单次IA注射HA + CS，两组均完成24周随访以评估疼痛和功能改善情况。主要结局指标是膝关节OA患者从基线到24周结束时24小时平均疼痛评分的每周均值变化，次要结局包括治疗反应、简明疼痛量表中相对于基线的变化、西安大略和麦克马斯特大学骨关节炎指数评分的改善、患者总体改善印象量表、医院焦虑抑郁量表以及24周随访期间的不良事件。数据将按意向性分析原则进行分析。
本研究已获得北京天坛医院机构伦理委员会批准（批准号：KY 2019 - 086 - 02）。研究结果将发表在同行评审期刊上，并在科学会议上展示。
ClinicalTrials.gov标识符：NCT04117893；预结果。
