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Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain.
Sponsor: Xuanwu Hospital, Beijing
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
Official title: Interventional Study on Paraspinal Muscle Degeneration Leading to Lumbar Degenerative Diseases
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
314
Start Date
2026-01-01
Completion Date
2028-09-01
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
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
Locations (1)
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China