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ACTIVE NOT RECRUITING
NCT07664267
NA

Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain

Sponsor: EverEx Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

BEHAVIORAL

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