- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940025
Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care
February 7, 2024 updated by: EverEx Inc.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tae Hyun Park, M.D.
- Phone Number: 82-70-7799-0812
- Email: bill@everex.co.kr
Study Locations
-
-
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Gyeonggi-do, Korea, Republic of, 11923
- Recruiting
- Hanyang University GURI Hospital
-
Contact:
- Seona Shin
- Phone Number: 82-10-4823-5694
- Email: seona135790@gmail.com
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Seoul, Korea, Republic of, 03082
- Recruiting
- Seoul National University Hospital
-
Contact:
- Ye Jin Jung, M.D.
- Phone Number: 82-10-7746-0239
- Email: dpwls9485@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MORT-LBP
Participants randomly assigned to this arm will use the app, MORT-LBP.
|
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.
|
Active Comparator: treatment as usual (TAU)
Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP).
|
In the control group, education and physiotherapy is delivered and self-exercise is recommended.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 weeks
|
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).
|
8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Time Frame: 4, 8, 12 weeks
|
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).
|
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
|
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).
|
8, 12 weeks
|
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Time Frame: 8, 12 weeks
|
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).
|
8, 12 weeks
|
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: 8, 12 weeks
|
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).
|
8, 12 weeks
|
Use of rescue medication
Time Frame: 4, 8, 12 weeks
|
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
|
4, 8, 12 weeks
|
Assessment of retention in treatment
Time Frame: 4, 8 weeks
|
Differences in retention rates between groups at 4, 8 weeks.
|
4, 8 weeks
|
Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)
Time Frame: 4, 12 weeks
|
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).
|
4, 12 weeks
|
Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
Time Frame: 4, 12 weeks
|
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).
|
4, 12 weeks
|
Functional disability assessed by Oswestry Disability Index (ODI)
Time Frame: 4, 12 weeks
|
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.
|
4, 12 weeks
|
Assessment of spinal alignment status measured by X-ray
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Assessment of Equilibrium Ability by Single-limb stance test
Time Frame: 4, 8, 12 weeks
|
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.
|
4, 8, 12 weeks
|
Assessment of Muscular Endurance by Prone bridge test and Borg CR10 Scale (2010)
Time Frame: 4, 8, 12 weeks
|
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).
|
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
|
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).
|
4, 8, 12 weeks
|
Changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D)
Time Frame: 4, 8, 12 weeks
|
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).
|
4, 8, 12 weeks
|
Changes of Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010)
Time Frame: 4, 8, 12 weeks
|
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).
|
4, 8, 12 weeks
|
Assessment of app usability by surveys
Time Frame: 4, 8 weeks
|
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.
|
4, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sam Yeol Chang, M.D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2023
Primary Completion (Estimated)
April 4, 2024
Study Completion (Estimated)
May 17, 2024
Study Registration Dates
First Submitted
July 3, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 11, 2023
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-ETH-02K-CTP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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