Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain (MORACureLBP)
17 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
156
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Gyeonggi-do
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Guri-si, Gyeonggi-do, Coréia do Sul
- Hanyang University Guri Hospital
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Gwangmyeong, Gyeonggi-do, Coréia do Sul
- Chung-Ang University Gwangmyeong Hospital
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Uijeongbu-si, Gyeonggi-do, Coréia do Sul
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Korea
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Seoul, Korea, Coréia do Sul
- Seoul National University Hospital
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Seoul
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Seoul, Seoul, Coréia do Sul
- Samsung Medical Center
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Seoul, Seoul, Coréia do Sul
- Kangbuk Samsung Hospital
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Seoul, Seoul, Coréia do Sul
- Nowon Eulji University Hospital
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Seoul, Seoul, Coréia do Sul
- Seoul Asan Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment Compliance Percentage at Weeks 4 and 8
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Cho Jae Hwan, MD, PhD, Asan Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de março de 2026
Conclusão Primária (Estimado)
20 de agosto de 2026
Conclusão do estudo (Estimado)
30 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de junho de 2026
Primeira postagem (Real)
24 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EX-CU-LB-02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .