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

NCT07664267 · tracked via the Priya Life Science South Korea tracker

Sponsor

EverEx Inc

Phase

Not applicable

Started

2026-03-19

Last updated

2026-06-24

Condition(s) studied

Chronic Low Back Pain

Investigational drug(s) / intervention(s)

MORA Cure LBPExercise Education and Self-Exercise

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.

Study 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria * Adults aged 19 years or older. * Participants with low back pain lasting for at least 12 weeks. * Participants with average low back pain intensity of 4 or higher on the Numeric Pain Rating Scale. * Participants who are able to undergo application-based treatment using a smartphone. * Participants who voluntarily decide to participate in the clinical trial and sign the informed consent form before the start of the trial. * Participants who, in the opinion of the principal investigator, are able to comply with the clinical investigation plan. Exclusion Criteria * History of previous spinal surgery. * History of spinal injection treatment within 1 month before screening. * History of spinal trauma within 3 months before screening. * Lower limb muscle strength of 3 or less on manual muscle testing, or lower limb radiating pain accompanied by motor dysfunction. * Grade 2 or higher spondylolisthesis on radiographic imaging. * Scoliosis, defined as Cobb angle of 25 degrees or greater with a clear structural cause based on the principal investigator's judgment, or kyphosis, defined as lumbar lordosis angle less than 0 degrees. * Red flag signs, such as paralysis symptoms including bladder or bowel dysfunction, or sudden unexplained weight loss. * Tumor, infection, metabolic bone disease, cognitive impairment, fibromyalgia, systemic inflammatory disease, or systemic inflammatory disorder. * Any other systemic or psychiatric condition that, in the opinion of the principal investigator, limits exercise therapy. * Current use of opioid analgesics with potency equal to or greater than morphine for any other disease or low back pain, such as oxycodone, fentanyl, or pethidine. Participants may participate after a 14-day washout period if applicable. * Pregnant participants, participants planning pregnancy during the clinical trial, or participants unable to maintain contraception during the clinical trial. * Current participation in another clinical trial or planned participation in another clinical trial during this study. * Inability to communicate, difficulty following instructions, or any other condition that, in the opinion of the principal investigator, makes the participant unsuitable for this clinical trial.

Primary outcome measure(s)

Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale — Week 4 and Week 12 after baseline
Usual low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.

Trial sites (8)

Facility	City	Region
Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Chung-Ang University Gwangmyeong Hospital	Gwangmyeong	Gyeonggi-do
The Catholic University of Korea Uijeongbu St. Mary's Hospital	Uijeongbu-si	Gyeonggi-do
Seoul National University Hospital	Seoul	Korea
Kangbuk Samsung Hospital	Seoul	Seoul
Nowon Eulji University Hospital	Seoul	Seoul
Samsung Medical Center	Seoul	Seoul
Seoul Asan Hospital	Seoul	Seoul

More EverEx Inc. trials in South Korea

A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome Active, not recruiting

MORA Cure for Knee Osteoarthritis With Anterior Knee Pain Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07664267 on ClinicalTrials.gov ↗ ← All trials in South Korea