Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain.
Starting soon · Not applicable
Conditions studied: Paraspinal Muscles, Low Back Pain, Machine Learning, Radiomics, Non-surgical Treatment
In brief
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
Key facts
- Study ID
- NCT07353372
- Run by
- Xuanwu Hospital, Beijing
- People needed
- 314
- Starts
- 2026-01-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-01-20
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Xuanwu Hospital,Capital Medical University — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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