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

NCT07664267 | Active Not Recruiting

• 1 other identifier: EX-CU-LB-02
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Chronic Low Back Pain

Keywords

LBP; Digital Health; MORA Cure; Everex; Low back pain; chronic low back pain (non-specific, uncomplicated); chronic low back pain; MORA; Digital therapeutics

Outcome Measures

Primary Outcomes (1)

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

  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.

  Week 4 and Week 12 after baseline

Secondary Outcomes (8)

• Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale

  Week 4, Week 8, and Week 12 after baseline

• Worst 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 wor

  Week 4, Week 8, and Week 12 after baseline

• Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index

  Week 4, Week 8, and Week 12 after baseline

• Health-related Quality of Life at Weeks 4, 8, and 12 Measured by EQ-5D-5L

  Week 4, Week 8, and Week 12 after baseline

• Change From Baseline in Usual Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale

  Baseline to Week 4, Week 8, and Week 12

Other Outcomes (6)

• Treatment Compliance Percentage at Weeks 4 and 8

  Week 4 and Week 8 after baseline

• Psychological Status at Weeks 8 and 12 Measured by the Patient Health Questionnaire-9

  Week 8 and Week 12 after baseline

• Pain Catastrophizing at Weeks 8 and 12 Measured by the Pain Catastrophizing Scale

  Week 8 and Week 12 after baseline

Study Arms (2)

MORA Cure Digital Therapeutic

EXPERIMENTAL

Participants assigned to the experimental group will use MORA Cure, a software-based digital therapeutic consisting of a patient mobile application and clinician web program. MORA Cure provides an 8-week app-based rehabilitation exercise program and cognitive behavioral therapy for chronic low back pain. Participants are recommended to use the device at least 3 times per week. After the 8-week treatment period, participants may use available content during the observation period through Week 12.

Device: MORA Cure LBP

Exercise Education and Self-Exercise

ACTIVE COMPARATOR

Participants assigned to the control group will receive disease education, exercise education, and self-exercise materials. Participants will perform self-exercise and record exercise performance in a self-exercise diary.

Behavioral: Exercise Education and Self-Exercise

Interventions

MORA Cure LBP DEVICE

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.

Also known as: ETH-02K; ETH-02KW

MORA Cure Digital Therapeutic

Exercise Education and Self-Exercise BEHAVIORAL

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.

Exercise Education and Self-Exercise

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EverEx Inc.: lead

Study Sites (8)

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Location

Seoul National University Hospital

Seoul, Korea, South Korea

Location

Kangbuk Samsung Hospital

Seoul, Seoul, South Korea

Location

Nowon Eulji University Hospital

Seoul, Seoul, South Korea

Location

Samsung Medical Center

Seoul, Seoul, South Korea

Location

Seoul Asan Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cho Jae Hwan, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomized in a 1:1 ratio to either the MORA Cure digital therapeutic group or the control group. Block randomization will be used. Randomization will be generated by an independent third-party institution and implemented through an interactive web response system. No stratification will be performed.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 24, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)