Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care
CompletedNot applicableNCT05940025
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-person Education Combined With Physiotherapy, a Randomized Controlled Pilot Study
- Conditions
- Interventions
- Device: MORT-LBP
- Other: treatment as usual (TAU)
- Sponsor
- EverEx Inc.
- Start date
- 2023-08-16
- Primary completion
- 2024-04-04
- Sex
- All
- Age range
- from 19 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- South Korea
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05940025