NCT05940025

Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care

Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-person Education Combined With Physiotherapy, a Randomized Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: EverEx Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	treatment as usual (TAU)	In the control group, education and physiotherapy is delivered and self-exercise is recommended.

Timeline

• Start date: 2023-08-16
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2023-07-11
• Last updated: 2024-07-31

Locations

2 sites across 1 country: South Korea