Chronic Low Back PainMORACureLBPNCT07664267
Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain
A study testing MORA Cure LBP and Exercise Education and Self-Exercise in people with Chronic Low Back Pain, run by EverEx Inc. at 8 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- MORA Cure LBP and Exercise Education and Self-Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 19 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, 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
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do
About this study
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
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.
Read the detailed description
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- MORA Cure LBP, Exercise Education and Self-Exercise
- Keywords
- LBP, Digital Health, MORA Cure, Everex, Low back pain, chronic low back pain (non-specific, uncomplicated), chronic low back pain, MORA, Digital therapeutics
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORA Cure LBPDevice
Also called ETH-02K; ETH-02KW
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-ExerciseBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise Education and Self-Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Week 4, Week 8, and Week 12 after baseline
Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline to Week 4, Week 8, and Week 12
Change From Baseline in Worst Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale
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.
Measured: Baseline to Week 4, Week 8, and Week 12
Change From Baseline in Functional Disability Measured by the Oswestry Disability Index
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.
Measured: Baseline to Week 4, Week 8, and Week 12
Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L
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.
Measured: Baseline to Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start19 Mar 2026
- Primary completion20 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EverEx Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cho Jae Hwan, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664267
- Sponsor's protocol ID
- EX-CU-LB-02
- Acronym
- MORACureLBP
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07664267
- Acronym / sponsor ID
- MORACureLBP / EX-CU-LB-02
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- EverEx Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MORA Cure Digital Therapeutic | Experimental | Device: MORA Cure LBPParticipants 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. |
| Exercise Education and Self-Exercise | Active comparator | Behavioral: Exercise Education and Self-ExerciseParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORA Cure LBPAlso: ETH-02K; ETH-02KWMORA 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. | Device | MORA Cure Digital Therapeutic |
| Exercise Education and Self-ExerciseParticipants 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. | Behavioural | Exercise Education and Self-Exercise |
Primary outcome
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.
8 secondary outcomes
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 wor
Time frame: Week 4, Week 8, and Week 12 after baseline
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
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
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 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 Functional Disability Measured by the Oswestry Disability Index
Time frame: Baseline to Week 4, Week 8, and Week 12
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cho Jae Hwan, MD, PhD principal investigator
Asan Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORA Cure LBP and Exercise Education and Self-Exercise in people with Chronic Low Back Pain, run by EverEx Inc. at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.