Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain (MORACureLBP)
17. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
156
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Gyeonggi-do
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Guri-si, Gyeonggi-do, Sør -Korea
- Hanyang University Guri Hospital
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Gwangmyeong, Gyeonggi-do, Sør -Korea
- Chung-Ang University Gwangmyeong Hospital
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Uijeongbu-si, Gyeonggi-do, Sør -Korea
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Korea
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Seoul, Korea, Sør -Korea
- Seoul National University Hospital
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Seoul
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Seoul, Seoul, Sør -Korea
- Samsung Medical Center
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Seoul, Seoul, Sør -Korea
- Kangbuk Samsung Hospital
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Seoul, Seoul, Sør -Korea
- Nowon Eulji University Hospital
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Seoul, Seoul, Sør -Korea
- Seoul Asan Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment Compliance Percentage at Weeks 4 and 8
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Cho Jae Hwan, MD, PhD, Asan Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. mars 2026
Primær fullføring (Antatt)
20. august 2026
Studiet fullført (Antatt)
30. september 2026
Datoer for studieregistrering
Først innsendt
11. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EX-CU-LB-02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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