Service de Médecine Physique et de Réadaptation, CHU Clermont-Ferrand, Université Clermont Auvergne, INRAE, UNH, F-63000, Clermont-Ferrand, France.
Service de Santé Publique, CHU de Clermont Ferrand, PEPRADE, Université Clermont Auvergne, Clermont-Ferrand, France.
Trials. 2023 Jan 19;24(1):45. doi: 10.1186/s13063-022-06879-5.
Osteoarthritis is a chronic pathology that involves multidisciplinary management. Self-management for patients is an essential element, present in all international guidelines. During the time of the spa therapy, the patient is receptive to take the advantage of self-management workshops. The aim of this study is to assess the effects of 18 days spa therapy associated with a self-management intervention in patients with knee osteoarthritis in comparison with spa therapy alone on a priority objective, personalized and determined with the patient, chosen in the list of 5 objectives determined during the self-management initial assessment.
Two hundred fifty participants with knee osteoarthritis will participate to this multicenter, prospective, randomized, controlled study. All patients will benefit 18 days of spa therapy and patients randomized in the intervention group will participate to 6 self-management workshops. Randomization will be centralized. The allocation ratio will be 1:1. Data analysts and assessor will be blinded. The primary outcome is the effectiveness of the educational workshops associated with spa therapy in comparison with spa therapy alone on a priority objective, measured by Goal Attainment Scaling (GAS). The secondary outcomes are disability, health-related quality of life, and pain intensity.
Ethics were approved by the CPP Sud-Méditerranée II. The results will be disseminated in a peer-reviewed journal and disseminated at PRM, rheumatology, and orthopedics conferences. The results will also be disseminated to patients.
Trial registration number NCT03550547. Registered 8 June 2018. Date and version identifier of the protocol. Version N°6 of March 12, 2018.
骨关节炎是一种涉及多学科管理的慢性疾病。患者的自我管理是所有国际指南都强调的重要内容。在温泉治疗期间，患者愿意参加自我管理研讨会。本研究的目的是评估 18 天温泉治疗联合自我管理干预对膝骨关节炎患者的影响，并与单独温泉治疗进行比较，主要疗效指标是患者在自我管理初始评估中确定的 5 个目标列表中选择的、个性化且患者确定的首要目标。
本研究为多中心、前瞻性、随机、对照研究，共纳入 250 例膝骨关节炎患者。所有患者均接受 18 天温泉治疗，随机分入干预组的患者还将参加 6 次自我管理研讨会。随机分组采用中央化随机分配。分配比例为 1:1。数据分析师和评估者将设盲。主要结局是通过目标达成量表（GAS）评估温泉治疗联合自我管理教育课程对首要目标的疗效，次要结局为残疾、健康相关生活质量和疼痛强度。
本研究已获得 CPP Sud-Méditerranée II 的伦理批准。研究结果将发表在同行评议期刊上，并在 PRM、风湿病学和骨科会议上进行传播。研究结果还将向患者传播。
试验注册号 NCT03550547。注册日期为 2018 年 6 月 8 日。方案的日期和版本标识符。版本号为 2018 年 3 月 12 日的第 6 版。
