Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain (MORACureLBP)
17 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Aktywny, nie rekrutujący
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
156
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Gyeonggi-do
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Guri-si, Gyeonggi-do, Korea Południowa
- Hanyang University Guri Hospital
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Gwangmyeong, Gyeonggi-do, Korea Południowa
- Chung-Ang University Gwangmyeong Hospital
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Uijeongbu-si, Gyeonggi-do, Korea Południowa
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Korea
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Seoul, Korea, Korea Południowa
- Seoul National University Hospital
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Seoul
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Seoul, Seoul, Korea Południowa
- Samsung Medical Center
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Seoul, Seoul, Korea Południowa
- Kangbuk Samsung Hospital
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Seoul, Seoul, Korea Południowa
- Nowon Eulji University Hospital
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Seoul, Seoul, Korea Południowa
- Seoul Asan Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
Inne nazwy:
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Aktywny komparator: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale
Ramy czasowe: Week 4 and Week 12 after baseline
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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.
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Week 4 and Week 12 after baseline
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale
Ramy czasowe: Week 4, Week 8, and Week 12 after baseline
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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.
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Week 4, Week 8, and Week 12 after baseline
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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
Ramy czasowe: Week 4, Week 8, and Week 12 after baseline
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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.
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Week 4, Week 8, and Week 12 after baseline
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Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index
Ramy czasowe: Week 4, Week 8, and Week 12 after baseline
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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.
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Week 4, Week 8, and Week 12 after baseline
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Health-related Quality of Life at Weeks 4, 8, and 12 Measured by EQ-5D-5L
Ramy czasowe: Week 4, Week 8, and Week 12 after baseline
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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.
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Week 4, Week 8, and Week 12 after baseline
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Change From Baseline in Usual Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale
Ramy czasowe: Baseline to Week 4, Week 8, and Week 12
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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.
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Baseline to Week 4, Week 8, and Week 12
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Change From Baseline in Worst Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale
Ramy czasowe: Baseline to Week 4, Week 8, and Week 12
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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.
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Baseline to Week 4, Week 8, and Week 12
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Change From Baseline in Functional Disability Measured by the Oswestry Disability Index
Ramy czasowe: Baseline to Week 4, Week 8, and Week 12
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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.
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Baseline to Week 4, Week 8, and Week 12
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Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L
Ramy czasowe: Baseline to Week 4, Week 8, and Week 12
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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.
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Baseline to Week 4, Week 8, and Week 12
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Treatment Compliance Percentage at Weeks 4 and 8
Ramy czasowe: Week 4 and Week 8 after baseline
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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.
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Week 4 and Week 8 after baseline
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Psychological Status at Weeks 8 and 12 Measured by the Patient Health Questionnaire-9
Ramy czasowe: Week 8 and Week 12 after baseline
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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.
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Week 8 and Week 12 after baseline
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Pain Catastrophizing at Weeks 8 and 12 Measured by the Pain Catastrophizing Scale
Ramy czasowe: Week 8 and Week 12 after baseline
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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.
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Week 8 and Week 12 after baseline
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Spinal Muscle Endurance Duration at Weeks 8 and 12 Measured by the Prone Bridge Test
Ramy czasowe: Week 8 and Week 12 after baseline
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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.
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Week 8 and Week 12 after baseline
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Radiographic Spinal Alignment Parameters at Week 8 Measured by Whole-spine Lateral X-ray
Ramy czasowe: Week 8 after baseline
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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.
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Week 8 after baseline
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Incidence of Adverse Events
Ramy czasowe: From informed consent through Week 12 and applicable safety follow-up period
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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.
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From informed consent through Week 12 and applicable safety follow-up period
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Cho Jae Hwan, MD, PhD, Asan Medical Center
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 marca 2026
Zakończenie podstawowe (Szacowany)
20 sierpnia 2026
Ukończenie studiów (Szacowany)
30 września 2026
Daty rejestracji na studia
Pierwszy przesłany
11 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
24 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
24 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EX-CU-LB-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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