Prospective, Randomized, Controlled Confirmatory Clinical Investigation to Evaluate the Safety and Efficacy of a Multidisciplinary Digital Therapeutics in Patients with Patellofemoral Pain Syndrome
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
- 216
- 试验地点
- 16
- 主要终点
- Usual pain severity assessed by the Visual Analogue Scale (VAS)
研究概览
简要总结
This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.
详细描述
This randomized controlled confirmatory study will enroll 216 participants, where half will be randomly assigned to the digital therapeutics (S/W medical device), MORA Cure (n = 108), and half will be assigned to treatment as usual (TAU) (n = 108), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The application provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
- •Patients with peripatellar or posterior patellar pain provoked by squatting
- •Patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, running, going up or down stairs, kneeling, compression of the patella, palpation of the patellar facets
- •Patients who signed a written informed consent form
排除标准
- •Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale
- •Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
- •Patients who had knee surgery within the last 3 months
- •Patients diagnosed with patellar tendinitis based on imaging within 3 months
- •Patients taking narcotic pain medications for pain control
- •Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening
- •Patients who are pregnant
- •Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening
- •Patients deemed unsuitable for this study by the investigator
结局指标
主要结局
Usual pain severity assessed by the Visual Analogue Scale (VAS)
时间窗: 8 weeks
Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
次要结局
- Treatment adherence(4 weeks, 8 weeks, 12 weeks)
- Usual pain severity assessed by the Visual Analogue Scale (VAS)(4 weeks, 12 weeks)
- Worst pain severity assessed by the Visual Analogue Scale (VAS)(4 weeks, 8 weeks, 12 weeks)
- Functional disability assessed by the Kujala Patellofemoral Scale(4 weeks, 8 weeks, 12 weeks)
- Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)(4 weeks, 8 weeks, 12 weeks)
- Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(4 weeks, 8 weeks, 12 weeks)
- Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)(4 weeks, 8 weeks, 12 weeks)
- Flexion and extension strength of knee(4 weeks, 8 weeks, 12 weeks)