drugset / Trial / NCT07353372

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

NCT07353372

Not yet recruiting 314 enrolled Xuanwu Hospital, Beijing
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2026-01-01
Primary completion
2028-09-01
Completion
2028-09-01

Drugs

EvaluationDrugModalityDoseRoute
Background Acetaminophen Small molecule Oral
Background Celecoxib Other / unclassified Oral
Background Ibuprofen Small molecule Oral

Indications

No indication recorded.