Trial Radar IA | ||
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Lo studio clinico NCT07353372 (METNLBP) per Paraspinal Muscles, Dolore lombare, Apprendimento automatico, Radiomica, Non-surgical Treatment è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain. (METNLBP) 314 Randomizzato Esercizio
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07353372 (METNLBP) è uno studio interventistico per Paraspinal Muscles, Dolore lombare, Apprendimento automatico, Radiomica, Non-surgical Treatment, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 gennaio 2026, con l'obiettivo di raggiungere 314 partecipanti. Sotto la guida di Xuanwu Hospital, Beijing, dovrebbe concludersi entro il 1 settembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 gennaio 2026.
Sommario breve
This multicenter, assessor-blinded, two-arm parallel randomized controlled trial (N = 314) will compare the efficacy and safety of a 6-week multidimensional exercise program plus usual pharmacological care (experimental arm) versus usual pharmacological care alone (control arm) in adults ≥ 60 years with chronic non-specific low-back pain (LBP) and imaging evidence of paraspinal muscle degeneration. The primary endpoi...Mostra di più
Descrizione dettagliata
Primary: to determine whether a 6-week supervised home-based multidimensional exercise program (aerobic, strength, balance, flexibility) added to short-term NSAIDs improves 12-month functional outcome (ODI) compared with NSAIDs alone.
Secondary: (1) compare pain intensity, quality of life, recurrence, and safety between arms; (2) develop and validate a radiomics-plus-machine-learning model that uses baseline MRI fea...
Mostra di piùTitolo ufficiale
Interventional Study on Paraspinal Muscle Degeneration Leading to Lumbar Degenerative Diseases
Patologie
Paraspinal MusclesDolore lombareApprendimento automaticoRadiomicaNon-surgical TreatmentAltri ID dello studio
- METNLBP
- xuanwu_LBP
Numero NCT
Data di inizio (effettiva)
2026-01-01
Ultimo aggiornamento pubblicato
2026-01-20
Data di completamento (stimata)
2028-09-01
Arruolamento (previsto)
314
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
Nonsteroidal anti-inflammatory drugs
Multidimensional exercise intervention
Multidimensional exercise intervention
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleMultidimensional Exercise+Standard Oral Medication Participants receive a 6-week multidimensional exercise intervention (including aerobic, strength, balance, and flexibility training) combined with standard oral NSAIDs (e.g., ibuprofen or celecoxib) for 4 weeks | Multidimensional exercise intervention Patients deemed by clinicians as not requiring surgical intervention and who consent to participate in the study will undergo an initial evaluation at the outpatient follow-up clinic. A multidimensional exercise intervention program and oral medication therapy (4 weeks) will be implemented based on the evaluation results. |
Comparatore attivoStandard Oral Medication Only Active ComparatorArm Description: Participants receive standard oral NSAIDs (e.g., ibuprofen or celecoxib) for 4 weeks without any structured exercise intervention. | Oral NSAIDs Participants receive the same 4-week oral NSAID regimen without structured exercise intervention |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in Oswestry Disability Index(ODI) score at 1 year post-treatment | 12 months after randomization |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
1.Change in Oswestry Disability Index (ODI) score. | Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention | |
atient satisfaction with treatment(Assessed by the North American Spine Society (NASS) satisfaction questionnaire) | 12 months post-intervention | |
Change in Visual Analogue Scale (VAS) score for low back pain | Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention | |
Change in Japanese Orthopaedic Association (JOA) score | Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention | |
Recurrence rate of low back pain(Defined as new episode lasting ≥24 h with VAS) | Baseline, end-of-intervention, 1 month, 3 months, 6 months post-intervention |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
60 Years
Sessi idonei
Tutti
- Age ≥ 60 years
- Chronic low-back pain for > 3 months (no surgical indication)
- Planned to receive conservative treatment
- Willing to participate and able to provide written informed consent
- Specific low-back pain due to infection, tumour, fracture, ankylosing spondylitis, scoliosis, or other structural spinal disorders
- Previous lumbar surgery or current surgical indication for lumbar disease 3.Severe cardiopulmonary, hepatic or renal insufficiency that precludes exercise or drug therapy
4.Severe cognitive impairment or psychiatric disorder preventing cooperation 5.Marked exercise limitations or physical disability precluding rehabilitation training 6.Participation in another clinical trial that could interfere with outcomes 7.Known hypersensitivity to any study medication
Xuanwu Hospital, BeijingContatti principali dello studio
Contatto: Xiaolong Chen, MD, +8613811839409, [email protected]
Contatto: Dongfan Wang, MD, +8618210728213, [email protected]
1 Centri dello studio in 1 paesi
Beijing Municipality
Xuanwu Hospital,Capital Medical University, Beijing, Beijing Municipality, 100053, China
Dongfan WANG, MD, Contatto, +8618210728213, [email protected]