Chronic Low Back Pain
Conditions
Keywords
LBP, Digital Health, MORA Cure, Everex, Low back pain, chronic low back pain (non-specific, uncomplicated), chronic low back pain, MORA, Digital therapeutics
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.
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.
Interventions
DEVICEMORA 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.
BEHAVIORALExercise 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.
Sponsors
EverEx Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 worst imaginable pain. Higher scores indicate worse pain intensity. |
| 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 | 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. |
| Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index | 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. |
| 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 | 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. |
| 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 | 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. |
| Change From Baseline in Worst Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale | 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. |
| Change From Baseline in Functional Disability Measured by the Oswestry Disability Index | 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. |
| Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORCho Jae Hwan, MD, PhD
Asan Medical Center
Outcome results
None listed