A Prospective, Multicenter, Single-Arm, Pilot Study to Evaluate the Clinical Outcomes and Safety of the Digital Therapeutic MORA Cure in Patients With Knee Osteoarthritis Accompanied by Anterior Knee Pain: 8-week
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- EverEx Inc.
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change From Baseline in Usual Overall Knee Pain Assessed by Visual Analog Scale at Week 8
研究概览
简要总结
This prospective, multicenter, single-arm, sponsor-initiated pilot study will evaluate the clinical course and safety of MORA Cure in adults older than 50 years with knee osteoarthritis accompanied by anterior knee pain. Participants will use MORA Cure for 8 weeks. MORA Cure provides personalized rehabilitation exercises and cognitive behavioral therapy-based content through a patient mobile application supported by a clinician web portal. Clinical outcomes will be assessed at baseline, Week 4, and Week 8. The planned enrollment is 44 participants at two sites in the Republic of Korea.
详细描述
The study includes a screening visit conducted within 4 weeks before baseline. The screening and baseline visits may occur on the same day; therefore, each participant will complete 3 or 4 outpatient visits. At baseline, the investigator will prescribe MORA Cure and assist with installation and initiation of the patient mobile application. Participants will use MORA Cure for 8 weeks, perform personalized rehabilitation exercises at least 3 times per week for approximately 30 minutes per session, and complete cognitive behavioral therapy content according to weekly sessions.
Assessments include usual and worst overall knee pain, usual and worst anterior knee pain using a 0-100 visual analog scale, the Knee injury and Osteoarthritis Outcome Score, the Anterior Knee Pain Scale (Kujala), the 30-second Sit-to-Stand Test, EQ-5D-5L and EQ-VAS, the Patient Health Questionnaire-9, the Pain Catastrophizing Scale, participant satisfaction, the System Usability Scale, and adverse events. Body weight and exercise performed outside MORA Cure are collected as exploratory factors.
This is a single-arm exploratory pilot study without a comparator group. Accordingly, observed changes cannot distinguish the effect of MORA Cure from natural improvement or other time-related factors. The Week 8 change in usual overall knee pain is designated as the primary outcome for registry organization only and will be interpreted as a principal exploratory outcome, not as confirmatory evidence of efficacy.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放(无盲法)
盲法说明
Open-label, single-arm study.
入排标准
- 年龄范围
- 51 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adults older than 50 years.
- Kellgren-Lawrence grade 1 or higher on weight-bearing plain radiographs of the study knee.
- Osteoarthritis-related pain in the study knee for at least 3 months.
- Anterior knee pain in the study knee involving the peripatellar, anterior patellar, or retropatellar region, with clear provocation or worsening of anterior knee pain during at least one patellofemoral joint-loading activity: stair ascent or descent, squatting, or rising from a chair.
- If medial, lateral, or posterior knee pain is also present, the participant is able to distinguish and separately report anterior knee pain.
- Voluntary written informed consent before study participation.
排除标准
- Acute injury of the study knee within the previous 3 months, including fracture, ligament tear, or meniscal tear requiring surgical treatment or immobilization.
- Injection therapy to the study knee within the previous 3 months.
- Current use of opioid analgesics for pain control.
- Does not own a smartphone or is unable to use the mobile application.
- Current participation in another clinical trial or planned participation in another clinical trial during this study.
- Diagnosed active inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or reactive arthritis.
- Acute attack of gout or pseudogout in the study knee within the previous 3 months.
- Previous total knee arthroplasty, corrective osteotomy, or other major surgery affecting knee alignment or joint structure in the study knee.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
研究组 & 干预措施
Experimental: MORA Cure
Participants will use MORA Cure for 8 weeks. Personalized rehabilitation exercises are performed at least 3 times per week for approximately 30 minutes per session, and cognitive behavioral therapy content is completed according to weekly sessions.
干预措施: MORA Cure (Device)
结局指标
主要结局
Change From Baseline in Usual Overall Knee Pain Assessed by Visual Analog Scale at Week 8
时间窗: Baseline and Week 8
Participants rate the average pain in the study knee over the previous 7 days on a 0-100 visual analog scale, where 0 indicates no pain and 100 indicates the worst imaginable pain. Change is calculated as the Week 8 score minus the baseline score; negative values indicate improvement.
次要结局
- Change From Baseline in Usual Overall Knee Pain Assessed by Visual Analog Scale at Week 4(Baseline and Week 4)
- Change From Baseline in Worst Overall Knee Pain Assessed by Visual Analog Scale(Baseline, Week 4, and Week 8)
- Change From Baseline in Usual Anterior Knee Pain Assessed by Visual Analog Scale(Baseline, Week 4, and Week 8)
- Change From Baseline in Worst Anterior Knee Pain Assessed by Visual Analog Scale(Baseline, Week 4, and Week 8)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07769593
- 其他研究编号
- EX-CU-KO-03
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (20天前)
- 研究完成日期
- (5个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Complete only if Yes
