Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care

NCT05940025 | Completed

• 1 other identifier: E-ETH-02K-CTP-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  8 weeks

Secondary Outcomes (16)

• Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)

  4, 12 weeks

• Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)

  4, 12 weeks

• Functional disability assessed by Oswestry Disability Index (ODI)

  4, 12 weeks

• Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)

  4, 8, 12 weeks

• Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

  8, 12 weeks

Study Arms (2)

MORT-LBP

EXPERIMENTAL

Participants randomly assigned to this arm will use the app, MORT-LBP.

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).

Other: treatment as usual (TAU)

Interventions

MORT-LBP DEVICE

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.

MORT-LBP

treatment as usual (TAU) OTHER

In the control group, education and physiotherapy is delivered and self-exercise is recommended.

treatment as usual (TAU)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EverEx Inc.: lead

Study Sites (2)

Hanyang University Guri Hospital

Gyeonggi-do, 11923, South Korea

Location

Seoul National University Hospital

Seoul, 03082, South Korea

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Sam Yeol Chang, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: August 16, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)