Back to resultsMultidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care
Primary Purpose
Chronic Low-back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MORT-LBP
treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
Eligibility Criteria
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
Sites / Locations
- Hanyang University Guri HospitalRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MORT-LBP
treatment as usual (TAU)
Arm Description
Participants randomly assigned to this arm will use the app, MORT-LBP.
Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP).
Outcomes
Primary Outcome Measures
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).
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).
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.
Secondary Outcome Measures
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).
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).
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.
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).
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).
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).
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).
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.
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.
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).
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).
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).
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).
Use of rescue medication
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
Assessment of retention in treatment
Differences in retention rates between groups at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05940025
Brief Title
Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care
Official Title
Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-person Education Combined With Physiotherapy, a Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EverEx Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MORT-LBP
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will use the app, MORT-LBP.
Arm Title
treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP).
Intervention Type
Device
Intervention Name(s)
MORT-LBP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
treatment as usual (TAU)
Intervention Description
In the control group, education and physiotherapy is delivered and self-exercise is recommended.
Primary Outcome Measure Information:
Title
Usual pain severity in the past week assessed by the Numeric Rating Scale (NRS)
Description
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).
Time Frame
8 weeks
Title
Worst pain severity in the past week assessed by the Numeric Rating Scale (NRS)
Description
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).
Time Frame
8 weeks
Title
Functional disability assessed by Oswestry Disability Index (ODI)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)
Description
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).
Time Frame
4, 12 weeks
Title
Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
Description
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).
Time Frame
4, 12 weeks
Title
Functional disability assessed by Oswestry Disability Index (ODI)
Description
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.
Time Frame
4, 12 weeks
Title
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
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).
Time Frame
8, 12 weeks
Title
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Description
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).
Time Frame
8, 12 weeks
Title
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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).
Time Frame
8, 12 weeks
Title
Assessment of spinal alignment status measured by X-ray
Description
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.
Time Frame
8 weeks
Title
Assessment of Equilibrium Ability by Single-limb stance test
Description
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.
Time Frame
4, 8, 12 weeks
Title
Assessment of Muscular Endurance by Prone bridge test and Borg CR10 Scale (2010)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Changes of usual and worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Changes of Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Use of rescue medication
Description
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
Time Frame
4, 8, 12 weeks
Title
Assessment of retention in treatment
Description
Differences in retention rates between groups at 4, 8 weeks.
Time Frame
4, 8 weeks
Title
Assessment of app usability by surveys
Description
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.
Time Frame
4, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Hyun Park, M.D.
Phone
82-70-7799-0812
Email
bill@everex.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Yeol Chang, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Guri Hospital
City
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seona Shin
Phone
82-10-4823-5694
Email
seona135790@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03082
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Jin Jung, M.D.
Phone
82-10-7746-0239
Email
dpwls9485@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care
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