Chronic Low-back PainNCT05940025
Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care
A study testing MORT-LBP and treatment as usual (TAU) in people with Chronic Low-back Pain, run by EverEx Inc. at 2 sites in South Korea.
Trial summary
This randomized controlled pilot study will be evaluating an app, MORT-LBP app (ETH-02K), owned by EverEx, Inc., to examine safety and efficacy in individuals with chronic lower back pain. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- MORT-LBP and treatment as usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 16 Aug 2023to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 19 and <65 years of age
- Patients who have a history of lower back pain persisting for longer than 12 weeks
- Patients who have average back pain score of 3 or more on the numeric rating scale (NRS)
- Patients who can use application-based therapy with his/her smartphone
- Patients who signed a written informed consent form
- Patients who are able to comply with the plan, as determined by the study investigator.
Who cannot join
- Patients who have previous history of spinal surgery
- Patients who have previous history of spinal trauma within 3 months
- Patients with lower extremity radicular pain with sensory and motor dysfunction
- Patients with lower extremity muscle strength of 3 or less on a manual muscle test
- Patients with spondylolysis or spondylolisthesis
- Patients with other structural abnormalities of the spine, including scoliosis (Cobb's angle > 10 degrees) or kyphosis (lordotic angle < 0 degrees)
Show all 13Show fewer
- Patients with red flag signs (paralyzing symptoms such as fecal impairment, sudden unexplained weight loss)
- Patients with tumors, infections, metabolic bone disease, cognitive impairment, fibromyalgia, and systemic inflammatory diseases
- Patients with other systemic disease conditions that limit exercise therapy, as determined by the study investigator
- Patients who are pregnant or breastfeeding
- Patients with known substance/alcohol use disorders
- Patients who are not able to participate in an exercise or strengthening program
- Patients taking opioid analgesic medications with a potency greater than or equal to tramadol for other conditions or low back pain
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Hanyang University Guri Hospital
Gyeonggi-do, 11923
Seoul National University Hospital
Seoul, 03082
About this study
Official title: Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-person Education Combined With Physiotherapy, a Randomized Controlled Pilot Study
This randomized controlled pilot study will be evaluating an app, MORT-LBP app (ETH-02K), owned by EverEx, Inc., to examine safety and efficacy in individuals with chronic lower back pain.
Read the detailed description
This randomized controlled pilot study will enroll 46 participants, where half will be randomly assigned to the app, MORT-LBP (n = 23), and half will be assigned to treatment as usual (TAU) (n = 23), to examine safety and efficacy in individuals with chronic lower back pain. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with chronic lower back pain.
- Conditions
- Chronic Low-back Pain
- Being tested
- MORT-LBP, treatment as usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORT-LBPDevice
The MORT-LBP, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioral therapy for patients with chronic lower back pain.
In the control group, education and physiotherapy is delivered and self-exercise is recommended.
| Study group | Role | What they receive |
|---|---|---|
| MORT-LBP | Experimental | Participants randomly assigned to this arm will use the app, MORT-LBP. Receives: Device: MORT-LBP |
| treatment as usual (TAU) | Active comparator | Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP). Receives: Other: treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usual pain severity in the past week assessed by the Numeric Rating Scale (NRS)
The primary outcome being measure is differences in usual pain severity in the past week between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 8 weeks
Worst pain severity in the past week assessed by the Numeric Rating Scale (NRS)
The primary outcome being measure is differences in worst pain severity in the past week between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 8 weeks
Functional disability assessed by Oswestry Disability Index (ODI)
The primary outcome being measure is differences in functional disability between groups after the intervention. Oswestry Disability Index (ODI) is a patient reported assessment of chronic lower back pain-specific functional limitations. It has 10 questions, total score ranging from 0 to 50, and ODI is calculated with (total score)/(answered question number * 5)*100%. Higher index means worse outcome.
Measured: 8 weeks
Secondary outcomes (16)
Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)
The secondary outcome being measure is differences in usual pain severity in the past week between groups at 4 and 12 weeks. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4, 12 weeks
Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
The secondary outcome being measure is differences in worst pain severity in the past week between groups at 4 and 12 weeks. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4, 12 weeks
Functional disability assessed by Oswestry Disability Index (ODI)
The secondary outcome being measure is differences in functional disability between groups at 4 and 12 weeks. Oswestry Disability Index (ODI) is a patient reported assessment of chronic lower back pain-specific functional limitations. It has 10 questions, total score ranging from 0 to 50, and ODI is calculated with (total score)/(answered question number * 5)*100%. Higher index means worse outcome.
Measured: 4, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
The secondary outcome being measure is differences in health-related quality of life between groups at 4, 8 and 12 weeks. It measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with three possible answers for each dimension (1=no problem, 2=moderate problem, 3=severe problem). The instrument also includes a visual analogue scale, which is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 4, 8, 12 weeks
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Differences in mental health symptoms between groups at 8, 12 weeks. The Patient Health Questionnaire-9 (PHQ-9) total score for the nine items ranges from 0 to 27 (higher scores indicating greater severity of depression).
Measured: 8, 12 weeks
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Differences in levels of catastrophic thinking between groups at 8, 12 weeks. The Pain Catastrophizing Scale (PCS) is a 13-item scale, with a total range of 0 to 52 (higher scores indicating higher amounts of pain catastrophizing).
Measured: 8, 12 weeks
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Differences in fear avoidance behaviours between groups at 8, 12 weeks. The Fear-Avoidance Beliefs Questionnaire (FABQ) is a 16-item scale, with a total range of 0 to 96 (higher scores indicating higher amounts of fear avoidance behaviours).
Measured: 8, 12 weeks
Assessment of spinal alignment status measured by X-ray
Differences in Cobb's angle, distances from the plumb line of C7, lumbar lordosis, pelvic tilt, pelvic incidence, sacral slope, and distances from the plumb line of C7 and posterosuperior edge of S1 vertebral body between group after intervention.
Measured: 8 weeks
Assessment of Equilibrium Ability by Single-limb stance test
Differences in single-limb stance test between group at 4, 8, 12 weeks. The single limb stance test measures how long a individual can stand on each leg for up to 20 seconds.
Measured: 4, 8, 12 weeks
Assessment of Muscular Endurance by Prone bridge test and Borg CR10 Scale (2010)
Differences in prone bridge test test between group at 4, 8, 12 weeks. The prone bridge test measures how long a individual can stand prone bridge test for up to 120 seconds. Afterward, Borg CR10 Scale (2010), the rating of perceived exertion after physical activity is measured. It ranges from 0 to 10 (higher scores indicating more sensation of hardness).
Measured: 4, 8, 12 weeks
Changes of usual and worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
The secondary outcome being measure is differences in changes of usual pain severity, worst pain severity, Oswestry Disability Index (ODI), EuroQol five-dimensional (EQ-5D), Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010) from baseline to 4, 8, and 12 weeks between groups. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4, 8, 12 weeks
Changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D)
The secondary outcome being measure is differences in changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D) from baseline to 4, 8, and 12 weeks between groups. Oswestry Disability Index (ODI) is a patient reported assessment of chronic lower back pain-specific functional limitations. It has 10 questions, total score ranging from 0 to 50, and ODI is calculated with (total score)/(answered question number * 5)*100%. Higher index means worse outcome. EQ-5D measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with three possible answers for each dimension (1=no problem, 2=moderate problem, 3=severe problem). The instrument also includes a visual analogue scale, which is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 4, 8, 12 weeks
Changes of Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010)
The secondary outcome being measure is differences in changes of single-limb stance test, prone bridge test and Borg CR10 Scale (2010) from baseline to 4, 8, and 12 weeks between groups. The single limb stance test measures how long a individual can stand on each leg for up to 20 seconds. The prone bridge test measures how long a individual can stand prone bridge test for up to 120 seconds. Afterward, Borg CR10 Scale (2010), the rating of perceived exertion after physical activity is measured. It ranges from 0 to 10 (higher scores indicating more sensation of hardness).
Measured: 4, 8, 12 weeks
Use of rescue medication
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
Measured: 4, 8, 12 weeks
Assessment of retention in treatment
Differences in retention rates between groups at 4, 8 weeks.
Measured: 4, 8 weeks
Assessment of app usability by surveys
Differences in app usability survey score between groups at 4, 8 weeks. The survey comprises 8 questions, with total score ranging from 0 to 40. Higher score indicates better user experience.
Measured: 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start16 Aug 2023
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
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
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- EverEx Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Yeol Chang, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940025
- Sponsor's protocol ID
- E-ETH-02K-CTP-01
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2023
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-person Education Combined With Physiotherapy, a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05940025
- Acronym / sponsor ID
- E-ETH-02K-CTP-01
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- EverEx Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 11 Jul 2023 (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 randomized controlled pilot study will be evaluating an app, MORT-LBP app (ETH-02K), owned by EverEx, Inc., to examine safety and efficacy in individuals with chronic lower back pain.
Detailed description
This randomized controlled pilot study will enroll 46 participants, where half will be randomly assigned to the app, MORT-LBP (n = 23), and half will be assigned to treatment as usual (TAU) (n = 23), to examine safety and efficacy in individuals with chronic lower back pain. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with chronic lower back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORT-LBP | Experimental | Device: MORT-LBPParticipants randomly assigned to this arm will use the app, MORT-LBP. |
| treatment as usual (TAU) | Active comparator | Other: treatment as usual (TAU)Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 19 and <65 years of age
- Patients who have a history of lower back pain persisting for longer than 12 weeks
- Patients who have average back pain score of 3 or more on the numeric rating scale (NRS)
- Patients who can use application-based therapy with his/her smartphone
- Patients who signed a written informed consent form
Key exclusion criteria (13 listed)
- Patients who have previous history of spinal surgery
- Patients who have previous history of spinal trauma within 3 months
- Patients with lower extremity radicular pain with sensory and motor dysfunction
- Patients with lower extremity muscle strength of 3 or less on a manual muscle test
- Patients with spondylolysis or spondylolisthesis
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 |
|---|---|---|
| MORT-LBPThe MORT-LBP, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioral therapy for patients with chronic lower back pain. | Device | MORT-LBP |
| treatment as usual (TAU)In the control group, education and physiotherapy is delivered and self-exercise is recommended. | Other | treatment as usual (TAU) |
Primary outcome
Usual pain severity in the past week assessed by the Numeric Rating Scale (NRS)
Time frame: 8 weeks
The primary outcome being measure is differences in usual pain severity in the past week between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Worst pain severity in the past week assessed by the Numeric Rating Scale (NRS)
Time frame: 8 weeks
The primary outcome being measure is differences in worst pain severity in the past week between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Functional disability assessed by Oswestry Disability Index (ODI)
Time frame: 8 weeks
The primary outcome being measure is differences in functional disability between groups after the intervention. Oswestry Disability Index (ODI) is a patient reported assessment of chronic lower back pain-specific functional limitations. It has 10 questions, total score ranging from 0 to 50, and ODI is calculated with (total score)/(answered question number * 5)*100%. Higher index means worse outcome.
16 secondary outcomes
Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)
Time frame: 4, 12 weeks
Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
Time frame: 4, 12 weeks
Functional disability assessed by Oswestry Disability Index (ODI)
Time frame: 4, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Time frame: 4, 8, 12 weeks
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 8, 12 weeks
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Time frame: 8, 12 weeks
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 8, 12 weeks
Assessment of spinal alignment status measured by X-ray
Time frame: 8 weeks
Assessment of Equilibrium Ability by Single-limb stance test
Time frame: 4, 8, 12 weeks
Assessment of Muscular Endurance by Prone bridge test and Borg CR10 Scale (2010)
Time frame: 4, 8, 12 weeks
Changes of usual and worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
Time frame: 4, 8, 12 weeks
Changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D)
Time frame: 4, 8, 12 weeks
Changes of Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010)
Time frame: 4, 8, 12 weeks
Use of rescue medication
Time frame: 4, 8, 12 weeks
Assessment of retention in treatment
Time frame: 4, 8 weeks
Assessment of app usability by surveys
Time frame: 4, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- 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.
Sam Yeol Chang, M.D. principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORT-LBP and treatment as usual (TAU) in people with Chronic Low-back Pain, run by EverEx Inc. at 2 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 pain severity in the past week assessed by the Numeric Rating Scale (NRS) (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 31 Jul 2024.