Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care

EverEx

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Other: treatment as usual (TAU); Device: MORT-LBP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05940025

E-ETH-02K-CTP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

MORT-LBP

Experimental group

Description:

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

Treatment:

Device: MORT-LBP

treatment as usual (TAU)

Active Comparator group

Description:

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

Treatment:

Other: treatment as usual (TAU)