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NCT Number: NCT07664267

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

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang University Guri Hospital, Guri-si, Gyeonggi-do, South Korea

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About this study

MORA Cure LBP is a software-based digital therapeutic intended to improve symptoms in patients with chronic low back pain by providing app-based exercise therapy and cognitive behavioral therapy. The investigational medical device consists of a patient mobile application and a clinician web program. Through the clinician web program, investigators can prescribe rehabilitation programs and monitor participants.

Participants assigned to the experimental group will use MORA Cure LBP for 8 weeks. Use of the device at least 3 times per week is recommended. After the 8-week treatment period, participants may continue to use available content during the follow-up observation period through Week 12.

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

Participants will attend 3 to 5 visits, including screening, baseline, Week 4, Week 8, and Week 12. The Week 4 visit may be conducted as a televisit. The Week 8 visit is the primary evaluation time point, and the Week 12 visit is the follow-up evaluation time point.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ETH-02K; ETH-02KW

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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 worst imaginable pain. Higher scores indicate worse pain intensity.

  2. 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

    Time frame: 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.

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

    Time frame: Week 4, Week 8, and Week 12 after baseline

    Functional disability related to low back pain will be assessed using the Oswestry Disability Index and compared between groups. The Oswestry Disability Index score ranges from 0 to 100, with higher scores indicating greater disability.

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

    Time frame: Week 4, Week 8, and Week 12 after baseline

    Health-related quality of life will be assessed using EQ-5D-5L and compared between groups. The EQ-5D-5L descriptive system includes 5 dimensions, each scored from 1 to 5. The total descriptive score ranges from 5 to 25, with higher scores indicating more problems and worse health-related quality of life. The EQ visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health status.

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

    Time frame: Baseline to Week 4, Week 8, and Week 12

    Change from baseline in 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. A negative change from baseline indicates improvement.

  6. Change From Baseline in Worst Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale

    Time frame: Baseline to Week 4, Week 8, and Week 12

    Change from baseline in 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 worst imaginable pain. Higher scores indicate worse pain intensity. A negative change from baseline indicates improvement.

  7. Change From Baseline in Functional Disability Measured by the Oswestry Disability Index

    Time frame: Baseline to Week 4, Week 8, and Week 12

    Change from baseline in functional disability related to low back pain will be assessed using the Oswestry Disability Index and compared between groups. The Oswestry Disability Index score ranges from 0 to 100, with higher scores indicating greater disability. A negative change from baseline indicates improvement.

  8. Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L

    Time frame: Baseline to Week 4, Week 8, and Week 12

    Change from baseline in health-related quality of life will be assessed using EQ-5D-5L and compared between groups. The EQ-5D-5L descriptive system includes 5 dimensions, each scored from 1 to 5. The total descriptive score ranges from 5 to 25, with higher scores indicating more problems and worse health-related quality of life. The EQ visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health status.

Other outcomes

  1. Treatment Compliance Percentage at Weeks 4 and 8

    Time frame: Week 4 and Week 8 after baseline

    Treatment compliance will be assessed as a percentage and compared between the MORA Cure group and the control group. In the MORA Cure group, compliance will be assessed using data from the clinician web program. In the control group, compliance will be assessed using the self-exercise diary. Compliance ranges from 0% to 100%, with higher percentages indicating better treatment compliance.

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

    Time frame: Week 8 and Week 12 after baseline

    Depression symptoms will be assessed using the Patient Health Questionnaire-9 and compared between groups. The Patient Health Questionnaire-9 score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.

  3. Pain Catastrophizing at Weeks 8 and 12 Measured by the Pain Catastrophizing Scale

    Time frame: Week 8 and Week 12 after baseline

    Pain catastrophizing will be assessed using the Pain Catastrophizing Scale and compared between groups. The Pain Catastrophizing Scale score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.

  4. Spinal Muscle Endurance Duration at Weeks 8 and 12 Measured by the Prone Bridge Test

    Time frame: Week 8 and Week 12 after baseline

    Spinal muscle endurance will be assessed using the prone bridge test and compared between groups. The outcome will be measured as the duration that the participant can maintain the prone bridge position, recorded in seconds. Higher values indicate better spinal muscle endurance.

  5. Radiographic Spinal Alignment Parameters at Week 8 Measured by Whole-spine Lateral X-ray

    Time frame: Week 8 after baseline

    Radiographic spinal alignment will be assessed using whole-spine lateral X-ray and compared between groups. The parameters include lumbar lordosis, pelvic tilt, pelvic incidence, sacral slope, and sagittal vertical axis. Angular parameters will be measured in degrees, and sagittal vertical axis will be measured in millimeters.

  6. Incidence of Adverse Events

    Time frame: From informed consent through Week 12 and applicable safety follow-up period

    Adverse events, adverse device effects, serious adverse events, and serious adverse device effects will be collected and summarized by treatment group. For adverse device effects, follow-up will be performed as applicable until 14 days after the last use of the investigational medical device.

Sponsors and collaborators

Lead sponsor

EverEx Inc.

Industry

Registry information

Official study 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

Acronym: MORACureLBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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