Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain (MORACureLBP)
17 июня 2026 г. обновлено: EverEx Inc.
A Prospective, Randomized, Open-label, Multicenter, Controlled, Comparative, Confirmatory Trial of MORA Cure in Patients With Chronic Low Back Pain: 8-week Evaluation and 12-week Follow-up
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.
Обзор исследования
Статус
Активный, не рекрутирующий
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
156
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Gyeonggi-do
-
Guri-si, Gyeonggi-do, Южная Корея
- Hanyang University Guri Hospital
-
Gwangmyeong, Gyeonggi-do, Южная Корея
- Chung-Ang University Gwangmyeong Hospital
-
Uijeongbu-si, Gyeonggi-do, Южная Корея
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
-
-
Korea
-
Seoul, Korea, Южная Корея
- Seoul National University Hospital
-
-
Seoul
-
Seoul, Seoul, Южная Корея
- Samsung Medical Center
-
Seoul, Seoul, Южная Корея
- Kangbuk Samsung Hospital
-
Seoul, Seoul, Южная Корея
- Nowon Eulji University Hospital
-
Seoul, Seoul, Южная Корея
- Seoul Asan Hospital
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: MORA Cure Digital Therapeutic
Participants assigned to the experimental group will use MORA Cure, a software-based digital therapeutic consisting of a patient mobile application and clinician web program.
MORA Cure provides an 8-week app-based rehabilitation exercise program and cognitive behavioral therapy for chronic low back pain.
Participants are recommended to use the device at least 3 times per week.
After the 8-week treatment period, participants may use available content during the observation period through Week 12.
|
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.
Другие имена:
|
|
Активный компаратор: Exercise Education and Self-Exercise
Participants assigned to the control group will receive disease education, exercise education, and self-exercise materials.
Participants will perform self-exercise and record exercise performance in a self-exercise diary.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale
Временное ограничение: Week 4 and Week 12 after baseline
|
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.
|
Week 4 and Week 12 after baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale
Временное ограничение: 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.
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.
|
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. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the wor
Временное ограничение: 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.
|
Week 4, Week 8, and Week 12 after baseline
|
|
Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index
Временное ограничение: Week 4, Week 8, and Week 12 after baseline
|
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.
|
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
Временное ограничение: Week 4, Week 8, and Week 12 after baseline
|
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.
|
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
Временное ограничение: Baseline to Week 4, Week 8, and Week 12
|
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.
|
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
Временное ограничение: Baseline to Week 4, Week 8, and Week 12
|
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.
|
Baseline to Week 4, Week 8, and Week 12
|
|
Change From Baseline in Functional Disability Measured by the Oswestry Disability Index
Временное ограничение: Baseline to Week 4, Week 8, and Week 12
|
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.
|
Baseline to Week 4, Week 8, and Week 12
|
|
Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L
Временное ограничение: Baseline to Week 4, Week 8, and Week 12
|
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.
|
Baseline to Week 4, Week 8, and Week 12
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Treatment Compliance Percentage at Weeks 4 and 8
Временное ограничение: Week 4 and Week 8 after baseline
|
Treatment compliance will be assessed as a percentage and compared between the MORA Cure group and the control group.
In the MORA Cure group, compliance will be assessed using data from the clinician web program.
In the control group, compliance will be assessed using the self-exercise diary.
Compliance ranges from 0% to 100%, with higher percentages indicating better treatment compliance.
|
Week 4 and Week 8 after baseline
|
|
Psychological Status at Weeks 8 and 12 Measured by the Patient Health Questionnaire-9
Временное ограничение: Week 8 and Week 12 after baseline
|
Depression symptoms will be assessed using the Patient Health Questionnaire-9 and compared between groups.
The Patient Health Questionnaire-9 score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
|
Week 8 and Week 12 after baseline
|
|
Pain Catastrophizing at Weeks 8 and 12 Measured by the Pain Catastrophizing Scale
Временное ограничение: Week 8 and Week 12 after baseline
|
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale and compared between groups.
The Pain Catastrophizing Scale score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
|
Week 8 and Week 12 after baseline
|
|
Spinal Muscle Endurance Duration at Weeks 8 and 12 Measured by the Prone Bridge Test
Временное ограничение: Week 8 and Week 12 after baseline
|
Spinal muscle endurance will be assessed using the prone bridge test and compared between groups.
The outcome will be measured as the duration that the participant can maintain the prone bridge position, recorded in seconds.
Higher values indicate better spinal muscle endurance.
|
Week 8 and Week 12 after baseline
|
|
Radiographic Spinal Alignment Parameters at Week 8 Measured by Whole-spine Lateral X-ray
Временное ограничение: Week 8 after baseline
|
Radiographic spinal alignment will be assessed using whole-spine lateral X-ray and compared between groups.
The parameters include lumbar lordosis, pelvic tilt, pelvic incidence, sacral slope, and sagittal vertical axis.
Angular parameters will be measured in degrees, and sagittal vertical axis will be measured in millimeters.
|
Week 8 after baseline
|
|
Incidence of Adverse Events
Временное ограничение: From informed consent through Week 12 and applicable safety follow-up period
|
Adverse events, adverse device effects, serious adverse events, and serious adverse device effects will be collected and summarized by treatment group.
For adverse device effects, follow-up will be performed as applicable until 14 days after the last use of the investigational medical device.
|
From informed consent through Week 12 and applicable safety follow-up period
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Cho Jae Hwan, MD, PhD, Asan Medical Center
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
19 марта 2026 г.
Первичное завершение (Оцененный)
20 августа 2026 г.
Завершение исследования (Оцененный)
30 сентября 2026 г.
Даты регистрации исследования
Первый отправленный
11 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
17 июня 2026 г.
Первый опубликованный (Действительный)
24 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
24 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- EX-CU-LB-02
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .