Interventional Study on Paraspinal Muscle Degeneration Leading to Lumbar Degenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 314
研究概览
简要总结
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
详细描述
Primary: to determine whether a 6-week supervised home-based multidimensional exercise program (aerobic, strength, balance, flexibility) added to short-term NSAIDs improves 12-month functional outcome (ODI) compared with NSAIDs alone.
Secondary: (1) compare pain intensity, quality of life, recurrence, and safety between arms; (2) develop and validate a radiomics-plus-machine-learning model that uses baseline MRI features of paraspinal muscles, demographic, clinical, and functional variables to predict treatment response and recurrence risk; (3) integrate the validated model with the exercise intervention to create a risk-stratified, early-intervention clinical pathway for chronic LBP.
Study Design：Multicenter, prospective, assessor-blinded, superiority RCT with 1:1 allocation, conducted at 4 tertiary hospitals and 1 academic research center in Beijing. Randomization (block sizes 4 and 6, stratified by center and sex) generated centrally via web-based system; allocation concealed from outcome assessors and statisticians.
Population Inclusion: age ≥ 60 y; LBP ≥ 3 months; ODI 20-60; MRI evidence of paraspinal muscle fatty infiltration ≥ Goutallier grade 2; no surgical indication; able to exercise.
Exclusion: specific spinal pathology (infection, tumor, fracture, severe deformity); previous lumbar surgery; severe comorbidities limiting exercise; cognitive impairment; current participation in another trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •4.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