Clinical trial NCT05940025: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: EverEx Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-11
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Usual pain severity in the past week assessed by the Numeric Rating Scale (NRS)
timeFrame: 8 weeks
measure: Worst pain severity in the past week assessed by the Numeric Rating Scale (NRS)
timeFrame: 8 weeks
measure: Functional disability assessed by Oswestry Disability Index (ODI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)
timeFrame: 4, 12 weeks
measure: Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
timeFrame: 4, 12 weeks
measure: Functional disability assessed by Oswestry Disability Index (ODI)
timeFrame: 4, 12 weeks
measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
timeFrame: 4, 8, 12 weeks
measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 8, 12 weeks
measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
timeFrame: 8, 12 weeks
measure: Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 8, 12 weeks
measure: Assessment of spinal alignment status measured by X-ray
timeFrame: 8 weeks
measure: Assessment of Equilibrium Ability by Single-limb stance test
timeFrame: 4, 8, 12 weeks
measure: Assessment of Muscular Endurance by Prone bridge test and Borg CR10 Scale (2010)
timeFrame: 4, 8, 12 weeks
measure: Changes of usual and worst pain severity in the past week assessed by Numeric Rating Scale (NRS)
timeFrame: 4, 8, 12 weeks
measure: Changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D)
timeFrame: 4, 8, 12 weeks
measure: Changes of Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010)
timeFrame: 4, 8, 12 weeks
measure: Use of rescue medication
timeFrame: 4, 8, 12 weeks
measure: Assessment of retention in treatment
timeFrame: 4, 8 weeks
measure: Assessment of app usability by surveys
timeFrame: 4, 8 weeks
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sam Yeol Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: