Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain

N/AActive Not RecruitingNCT07664267

EverEx Inc.156 enrolled

Overview

This is a prospective, randomized, open-label, multicenter, controlled, comparative, confirmatory clinical trial to evaluate the safety and efficacy of MORA Cure LBP, a multidisciplinary digital therapeutic, in patients with chronic low back pain. Eligible participants will be randomized in a 1:1 ratio to either the experimental group using MORA Cure LBP or the control group receiving exercise education and self-exercise materials. The treatment period is 8 weeks, followed by a 4-week observation period, for a total study period of 12 weeks from baseline. The primary efficacy endpoint is usual low back pain intensity during the past week measured by the 11-point Numeric Pain Rating Scale at Week 8.

MORA Cure LBP is a software-based digital therapeutic intended to improve symptoms in patients with chronic low back pain by providing app-based exercise therapy and cognitive behavioral therapy. The investigational medical device consists of a patient mobile application and a clinician web program. Through the clinician web program, investigators can prescribe rehabilitation programs and monitor participants. Participants assigned to the experimental group will use MORA Cure LBP for 8 weeks. Use of the device at least 3 times per week is recommended. After the 8-week treatment period, participants may continue to use available content during the follow-up observation period through Week 12. Participants assigned to the control group will receive disease education, self-exercise education, and self-exercise materials. They will perform self-exercise and record exercise performance in a self-exercise diary. Participants will attend 3 to 5 visits, including screening, baseline, Week 4, Week 8, and Week 12. The Week 4 visit may be conducted as a televisit. The Week 8 visit is the primary evaluation time point, and the Week 12 visit is the follow-up evaluation time point.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

MORA Cure LBPDEVICE

MORA Cure is a digital therapeutic software intended to improve symptoms in patients with chronic low back pain by providing exercise therapy and cognitive behavioral therapy through a patient mobile application and clinician web program.

Exercise Education and Self-ExerciseBEHAVIORAL

Participants will receive education regarding chronic low back pain and self-exercise based on the control group exercise education materials. Participants will perform self-exercise and record exercise performance in a self-exercise diary.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria * Adults aged 19 years or older. * Participants with low back pain lasting for at least 12 weeks. * Participants with average low back pain intensity of 4 or higher on the Numeric Pain Rating Scale. * Participants who are able to undergo application-based treatment using a smartphone. * Participants who voluntarily decide to participate in the clinical trial and sign the informed consent form before the start of the trial. * Participants who, in the opinion of the principal investigator, are able to comply with the clinical investigation plan. Exclusion Criteria * History of previous spinal surgery. * History of spinal injection treatment within 1 month before screening. * History of spinal trauma within 3 months before screening. * Lower limb muscle strength of 3 or less on manual muscle testing, or lower limb radiating pain accompanied by motor dysfunction. * Grade 2 or higher spondylolisthesis on radiographic imaging. * Scoliosis, defined as Cobb angle of 25 degrees or greater with a clear structural cause based on the principal investigator's judgment, or kyphosis, defined as lumbar lordosis angle less than 0 degrees. * Red flag signs, such as paralysis symptoms including bladder or bowel dysfunction, or sudden unexplained weight loss. * Tumor, infection, metabolic bone disease, cognitive impairment, fibromyalgia, systemic inflammatory disease, or systemic inflammatory disorder. * Any other systemic or psychiatric condition that, in the opinion of the principal investigator, limits exercise therapy. * Current use of opioid analgesics with potency equal to or greater than morphine for any other disease or low back pain, such as oxycodone, fentanyl, or pethidine. Participants may participate after a 14-day washout period if applicable. * Pregnant participants, participants planning pregnancy during the clinical trial, or participants unable to maintain contraception during the clinical trial. * Current participation in another clinical trial or planned participation in another clinical trial during this study. * Inability to communicate, difficulty following instructions, or any other condition that, in the opinion of the principal investigator, makes the participant unsuitable for this clinical trial.

Locations (8)

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Korea, South Korea

Kangbuk Samsung Hospital

Seoul, Seoul, South Korea

Nowon Eulji University Hospital

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Seoul Asan Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale

Usual low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.

Time frame: Week 4 and Week 12 after baseline

Secondary Outcomes

Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale

Worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.

Time frame: Week 4, Week 8, and Week 12 after baseline

Worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups.

Time frame: Week 4, Week 8, and Week 12 after baseline

Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index

Functional disability related to low back pain will be assessed using the Oswestry Disability Index and compared between groups. The Oswestry Disability Index score ranges from 0 to 100, with higher scores indicating greater disability.

Time frame: Week 4, Week 8, and Week 12 after baseline

Health-related Quality of Life at Weeks 4, 8, and 12 Measured by EQ-5D-5L

Health-related quality of life will be assessed using EQ-5D-5L and compared between groups. The EQ-5D-5L descriptive system includes 5 dimensions, each scored from 1 to 5. The total descriptive score ranges from 5 to 25, with higher scores indicating more problems and worse health-related quality of life. The EQ visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health status.

Time frame: Week 4, Week 8, and Week 12 after baseline

Change From Baseline in Usual Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale

Change from baseline in usual low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity. A negative change from baseline indicates improvement.

Time frame: Baseline to Week 4, Week 8, and Week 12

Change From Baseline in Worst Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale

Change from baseline in worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity. A negative change from baseline indicates improvement.

Time frame: Baseline to Week 4, Week 8, and Week 12

Change From Baseline in Functional Disability Measured by the Oswestry Disability Index

Change from baseline in functional disability related to low back pain will be assessed using the Oswestry Disability Index and compared between groups. The Oswestry Disability Index score ranges from 0 to 100, with higher scores indicating greater disability. A negative change from baseline indicates improvement.

Time frame: Baseline to Week 4, Week 8, and Week 12

Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L

Change from baseline in health-related quality of life will be assessed using EQ-5D-5L and compared between groups. The EQ-5D-5L descriptive system includes 5 dimensions, each scored from 1 to 5. The total descriptive score ranges from 5 to 25, with higher scores indicating more problems and worse health-related quality of life. The EQ visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health status.

Time frame: Baseline to Week 4, Week 8, and Week 12

Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes