Clinical Trial

Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain.

Study acronym: METNLBP
Not Yet Recruiting
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Summary
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 endpoint is change in Oswestry Disability Index (ODI) at 12 months. Secondary endpoints include pain VAS, JOA score, recurrence rate, and patient satisfaction measured repeatedly to 12 months. Advanced MRI radiomics and machine-learning algorithms will be used to build a "paraspinal muscle imaging-function-prognosis" prediction model and an open-access web tool for risk stratification. The study will generate a standardized, evidence-based non-operative care pathway for chronic LBP driven by paraspinal muscle degeneration
Trial Details
NCT Number NCT07353372
Lead Sponsor Xuanwu Hospital, Beijing
Conditions Paraspinal Muscles, Low Back Pain, Machine Learning, Radiomics, Non-surgical Treatment
Enrollment 314 participants
Start Date 2026-01-01
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-20