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Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain
Sponsor: EverEx Inc.
Summary
This is a prospective, randomized, open-label, multicenter, controlled, comparative, confirmatory clinical trial to evaluate the safety and efficacy of MORA Cure LBP, a multidisciplinary digital therapeutic, in patients with chronic low back pain. Eligible participants will be randomized in a 1:1 ratio to either the experimental group using MORA Cure LBP or the control group receiving exercise education and self-exercise materials. The treatment period is 8 weeks, followed by a 4-week observation period, for a total study period of 12 weeks from baseline. The primary efficacy endpoint is usual low back pain intensity during the past week measured by the 11-point Numeric Pain Rating Scale at Week 8.
Official title: A Prospective, Randomized, Open-label, Multicenter, Controlled, Comparative, Confirmatory Trial of MORA Cure in Patients With Chronic Low Back Pain: 8-week Evaluation and 12-week Follow-up
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2026-03-19
Completion Date
2026-09-30
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
MORA Cure LBP
MORA Cure is a digital therapeutic software intended to improve symptoms in patients with chronic low back pain by providing exercise therapy and cognitive behavioral therapy through a patient mobile application and clinician web program.
Exercise Education and Self-Exercise
Participants will receive education regarding chronic low back pain and self-exercise based on the control group exercise education materials. Participants will perform self-exercise and record exercise performance in a self-exercise diary.
Locations (8)
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Korea, South Korea
Kangbuk Samsung Hospital
Seoul, Seoul, South Korea
Nowon Eulji University Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Seoul Asan Hospital
Seoul, Seoul, South Korea