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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Oral NSAIDs: Participants receive the same 4-week oral NSAID regimen without structured exercise intervention

Study 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

Eligibility

Primary outcome measure(s)

• Change in Oswestry Disability Index(ODI) score at 1 year post-treatment — 12 months after randomization

Trial sites (1)

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition