Abstract：
BACKGROUND: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired.
OBJECTIVE: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).
METHODS: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.
RESULTS: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024.
CONCLUSIONS: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product.
BACKGROUND: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054.
UNASSIGNED: RR1-10.2196/13642.
OBJECTIVE: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).
METHODS: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.
RESULTS: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024.
CONCLUSIONS: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product.
BACKGROUND: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054.
UNASSIGNED: RR1-10.2196/13642.
摘要：
背景：骨关节炎（OA）是一种致残疾病，影响65岁以上人群的三分之一以上。目前,这些患者中有80％报告运动受限，20%的人无法进行主要的日常生活活动，大约11%需要个人护理。2014年，欧洲骨质疏松症和骨关节炎临床和经济方面协会（ESCEO）建议，作为膝骨关节炎药物治疗的第一步,使用慢性有症状的缓慢作用的骨关节炎药物如硫酸葡糖胺的背景疗法，硫酸软骨素，和透明质酸。后者已在临床试验中广泛评估为关节内和口服给药。最近的评论表明，对口服透明质酸的研究通常仅使用主观参数来测量症状，如视觉模拟量表或生活质量问卷。因此,缺乏客观措施，数据有效性通常会受到损害。
目的：这项使用口服透明质酸的初步研究的主要目标是评估使用客观工具作为评估膝关节活动度改善的结果的可行性。我们建议使用测角仪进行超声和运动范围测量，该测角仪可以客观地将关节活动度的变化与疼痛减轻相关联，通过视觉模拟量表评估。次要目标是收集数据以估计主要双盲研究随机试验的时间和预算。这些数据可能是定量的(例如每月的入学率，筛选失败的数量，和新的潜在结果)和定性(如现场后勤问题，患者不愿参加，和调查人员的人际关系困难)。
方法：这项开放标签的试点和可行性研究是在骨科诊所进行的（Timisoara，罗马尼亚)。这项研究包括男性和女性参与者，50-70岁,已被诊断为有症状的膝关节OA，并经历了至少6个月的轻度关节不适。必须招募八名患者并用Syalox300Plus（RiverPharma）治疗8周。它是一种含有高分子量透明质酸的膳食补充剂，它已经在几个欧洲国家销售。在基线和最终访问时进行评估。
结果：8名患者的招募和治疗于2018年2月15日开始，并于2018年5月25日完成。数据分析计划于2018年底完成。该研究于2019年2月获得资助。我们预计这些结果将在2024年最后一个季度发表在同行评审的临床期刊上。
结论：这项初步研究的数据将用于评估未来OA随机临床试验的可行性。特别是,计划的结果(例如，超声和运动范围)，安全,并且必须对定量和定性数据进行评估，以提前估算未来主要研究所需的时间和预算。最后,试点研究应提供有关研究产品疗效的初步信息.
背景：ClinicalTrials.govNCT03421054;https://clinicaltrials.gov/study/NCT03421054。
■RR1-10.2196/13642。
目的：这项使用口服透明质酸的初步研究的主要目标是评估使用客观工具作为评估膝关节活动度改善的结果的可行性。我们建议使用测角仪进行超声和运动范围测量，该测角仪可以客观地将关节活动度的变化与疼痛减轻相关联，通过视觉模拟量表评估。次要目标是收集数据以估计主要双盲研究随机试验的时间和预算。这些数据可能是定量的(例如每月的入学率，筛选失败的数量，和新的潜在结果)和定性(如现场后勤问题，患者不愿参加，和调查人员的人际关系困难)。
方法：这项开放标签的试点和可行性研究是在骨科诊所进行的（Timisoara，罗马尼亚)。这项研究包括男性和女性参与者，50-70岁,已被诊断为有症状的膝关节OA，并经历了至少6个月的轻度关节不适。必须招募八名患者并用Syalox300Plus（RiverPharma）治疗8周。它是一种含有高分子量透明质酸的膳食补充剂，它已经在几个欧洲国家销售。在基线和最终访问时进行评估。
结果：8名患者的招募和治疗于2018年2月15日开始，并于2018年5月25日完成。数据分析计划于2018年底完成。该研究于2019年2月获得资助。我们预计这些结果将在2024年最后一个季度发表在同行评审的临床期刊上。
结论：这项初步研究的数据将用于评估未来OA随机临床试验的可行性。特别是,计划的结果(例如，超声和运动范围)，安全,并且必须对定量和定性数据进行评估，以提前估算未来主要研究所需的时间和预算。最后,试点研究应提供有关研究产品疗效的初步信息.
背景：ClinicalTrials.govNCT03421054;https://clinicaltrials.gov/study/NCT03421054。
■RR1-10.2196/13642。
