Frontostriatal Connectivity and Gene Expression in Exercise-induced Relief of Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Chronic Low Back Pain Intensity
研究概览
简要总结
This study is registered retrospectively for transparency. This mechanistic randomized controlled trial examined whether a 14-week supervised physical exercise training program reduces chronic low back pain (CLBP) by modulating frontostriatal brain connectivity and immune-related gene expression. Fifty-seven adults with CLBP were randomized to exercise training or wait-list control. Participants underwent pre- and post-intervention MRI, questionnaires, and blood sampling. The study tested whether reductions in nucleus accumbens-medial prefrontal cortex connectivity and changes in inflammatory gene expression mediated exercise-induced pain relief.
详细描述
Chronic low back pain (CLBP) is associated with altered functional connectivity between the nucleus accumbens (NAc) and medial prefrontal cortex (mPFC), as well as systemic low-grade inflammation.
This mechanistic randomized controlled trial evaluated the effects of a 14-week supervised physical exercise (PE) training program on pain intensity, functional disability, brain connectivity, and peripheral gene expression in individuals with CLBP.
Participants were randomized to either:
- Supervised exercise training (3 sessions per week, 60 minutes per session, 14 weeks), or
- Wait-list control.
Exercise sessions combined aerobic and resistance training. Exercise intensity was individually calibrated based on VO2max and 1 repetition maximum (1RM) assessments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Chronic low back pain ≥ 3 months
- •Pain present at least half the days over the past 6 months
- •Average pain intensity ≥ 3/10 during week prior to enrollment
排除标准
- •Neurological disorder
- •Psychiatric disorder
- •Significant cardiorespiratory disease
- •Under 18 years of age
研究组 & 干预措施
Active intervention
Physical exercise training
干预措施: Supervised physical exercise training (Behavioral)
Waitlist control
Participants underwent all assessments but did not receive exercise training during the 14-week study period.
结局指标
主要结局
Chronic Low Back Pain Intensity
时间窗: Assessed at Baseline (Pre-intervention, Week 0) and Post-intervention (Week 14)
Self-reported average low back pain intensity measured using an 11-point Numerical Rating Scale (NRS; 0-10), where 0 = "no pain" and 10 = "worst imaginable pain."
次要结局
- Oswestry Low Back Pain Disability Index (ODI)(Assessed at Baseline (Week 0) and Post-intervention (Week 14))
- Whole-Brain Intrinsic Connectivity(MRI acquired at Baseline (Week 0) and Post-intervention (Week 14))
- Nucleus Accumbens-Medial Prefrontal Cortex Functional Connectivity(MRI acquired at Baseline (Week 0) and Post-intervention (Week 14))
- Fractional Anisotropy of NAc-mPFC White Matter Tract(MRI acquired at Baseline (Week 0) and Post-intervention (Week 14))
- Peripheral Blood Gene Expression (RNA Sequencing)(Blood samples collected prior to Session 7 (first calibrated-intensity session, Week 3) and prior to Session 42 (final session, Week 14))
- Plasma Brain-Derived Neurotrophic Factor (BDNF)(Collected immediately before and after Session 7 (Week 3) and immediately before and after Session 42 (Week 14))