Active — Not RecruitingNot Applicable

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

South Korea156 participantsStarted 2026-03-19

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale

Timeframe: Week 4 and Week 12 after baseline

Trial details

NCT IDNCT07664267

SponsorEverEx Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-20

View on ClinicalTrials.gov More Chronic Low Back Pain trials