Anterior Knee Pain, Knee Osteoarthritis
Conditions
Keywords
MORA Cure, Everex, Personalized Rehabilitation Exercise, Knee Pain
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMORA Cure
MORA Cure consists of a clinician web program (ETH-01KW) and a patient mobile application (ETH-01K). At baseline, the investigator registers the participant and issues a prescription code. The participant installs the application and uses it for 8 weeks. The application collects symptom information and AI-based movement assessment results, provides personalized rehabilitation exercises at least 3 times per week for approximately 30 minutes per session, adjusts exercise load based on participant data, and provides weekly cognitive behavioral therapy content. The application is deleted at Week 8.
Sponsors
EverEx Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label, single-arm study.
Intervention model description
Open-label, single-arm study
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults older than 50 years. 2. Kellgren-Lawrence grade 1 or higher on weight-bearing plain radiographs of the study knee. 3. Osteoarthritis-related pain in the study knee for at least 3 months. 4. 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. 5. If medial, lateral, or posterior knee pain is also present, the participant is able to distinguish and separately report anterior knee pain. 6. Voluntary written informed consent before study participation.
Exclusion criteria
1. Acute injury of the study knee within the previous 3 months, including fracture, ligament tear, or meniscal tear requiring surgical treatment or immobilization. 2. Injection therapy to the study knee within the previous 3 months. 3. Current use of opioid analgesics for pain control. 4. Does not own a smartphone or is unable to use the mobile application. 5. Current participation in another clinical trial or planned participation in another clinical trial during this study. 6. Diagnosed active inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or reactive arthritis. 7. Acute attack of gout or pseudogout in the study knee within the previous 3 months. 8. Previous total knee arthroplasty, corrective osteotomy, or other major surgery affecting knee alignment or joint structure in the study knee. 9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Usual Overall Knee Pain Assessed by Visual Analog Scale at Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Usual Overall Knee Pain Assessed by Visual Analog Scale at Week 4 | Baseline and Week 4 | Same 0-100 scale and scoring direction as the primary outcome. Change is Week 4 minus baseline; negative values indicate improvement. |
| Change From Baseline in Worst Overall Knee Pain Assessed by Visual Analog Scale | Baseline, Week 4, and Week 8 | Worst pain in the study knee over the previous 7 days is rated on a 0-100 visual analog scale, where higher scores indicate worse pain. Negative change indicates improvement. |
| Change From Baseline in Usual Anterior Knee Pain Assessed by Visual Analog Scale | Baseline, Week 4, and Week 8 | Average pain over the previous 7 days in the peripatellar, anterior patellar, or retropatellar region is rated on a 0-100 visual analog scale. Higher scores indicate worse pain; negative change indicates improvement |
| Change From Baseline in Worst Anterior Knee Pain Assessed by Visual Analog Scale | Baseline, Week 4, and Week 8 | Worst anterior knee pain over the previous 7 days is rated on a 0-100 visual analog scale. Higher scores indicate worse pain; negative change indicates improvement. |
Countries
South Korea
Outcome results
None listed