Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care

NCT ID: NCT05940025

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2024-04-04

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MORT-LBP

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

Group Type: EXPERIMENTAL

MORT-LBP

Intervention Type: 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.

treatment as usual (TAU)

Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP).

Group Type: ACTIVE_COMPARATOR

treatment as usual (TAU)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

treatment as usual (TAU)

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EverEx Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Yeol Chang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Hanyang University Guri Hospital

Gyeonggi-do, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

E-ETH-02K-CTP-01

Identifier Type: -

Identifier Source: org_study_id