跳至主要内容
临床试验/NCT07134699
NCT07134699招募中不适用

The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: A Longitudinal Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Pain intensity assessment

研究概览

简要总结

Chronic non-specific low back pain (CNSLBP) is a common condition among older adults and has been associated with an increased risk of executive function impairment. Research shows that older adults experiencing chronic pain are more likely to show worse cognitive performance compared to healthy individuals. While there is a bidirectional relationship between pain and executive functions, cognitive performance especially for some executive functions (e.g. inhibition, switching, working memory) is crucial for managing pain in older adults. Furthermore, executive dysfunctions are associated with decline in functional status among the population, particularly in performing instrumental activities in daily living. Therefore, maintaining executive function emerges as a pivotal consideration for older adults with CNSLBP.

Studies provide preliminary evidence that connects brain changes with chronic pain and cognitive functions. For instance, multisite chronic pain may increase the risk of cognitive decline through structural changes like hippocampal atrophy. Besides, functional brain changes in chronic pain may reduce deactivation several key default mode network regions, predisposing individuals to cognitive impairments. Despite the aforementioned brain changes, no direct evidence supports the hypothesis that structural and functional brain changes caused by CNSLBP in older adults may be associated with cognitive decline. It remains unclear that whether structural changes (e.g. reduced hippocampal, cerebellar gray matter, white matter volume in the right frontal region) and/or functional changes (e.g. deactivation of default mode network regions, heightened activation in the anterior cingulate cortex) cause by CNSLBP are associated with cognitive decline. With neuroimaging techniques, brain mechanisms connecting CNSLBP and executive function deficits can be explained.

To deepen understanding of the brain mechanisms underlying executive function decline in older adults with CNSLBP, this study will directly compare pain intensity, executive functions, brain structure, and functional changes of the brain between older adults with CNSLBP and age-matched healthy controls. A longitudinal approach is established to quantify the relationship between CNSLBP-related brain changes and executive functions in older adults, providing insights into the development of new treatment strategies to improve or prevent executive function decline in older adults with CNSLBP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Older adults with and without chronic non-specific low back pain (CNSLBP) aged between 60 and 85 years
  • •Having normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 26)13
  • •Right-handed
  • •Cantonese speaking
  • •Having at least 6 years of formal education and know how to read and write Chinese
  • •Agreeing to sign an informed consent form
  • •Being able to communicate via email or text message because several study measures will be collected electronically.

排除标准

  • •Inability to ambulate without assistance from another person (canes or walkers will be allowed)
  • •Having specific causes of LBP (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection)
  • •Having other concurrent musculoskeletal conditions at other body parts (e.g., fibromyalgia, or neck or knee pain)
  • •Self-reported history of lumbar or lower extremity surgery
  • •Self-reported history of neurological or psychiatric disorders (e.g., stroke, brain surgery, head trauma; schizophrenia, multiple personality disorder, dissociative identity disorder, stroke) or self-reported cancer history
  • •Self-reported specific inflammatory disorder: rheumatoid arthritis, rheumatica, scleroderma, lupus, or polymyositis
  • •Unexplained, unintended weight loss of 20 lbs or more in the past year
  • •Cauda equina syndrome
  • •Uncorrected visual deficit
  • •Drug or alcohol addiction
  • •Taking alcohol, opioids or benzodiazepines medicines 24 hours before the experiment
  • •Claustrophobia
  • •Contraindications for undergoing the magnetic resonance imaging (MRI) examination based on the MRI safety screening form of University Research Facility in Behavioral and Systems Neuroscience at The Hong Kong Polytechnic University

结局指标

主要结局

Pain intensity assessment

时间窗: Baseline and 6 months

11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.

Brain imaging

时间窗: Baseline, 6 months

Perform the following MRI sequences: T1-weighted, T2-weighted, DTI (diffusion tensor imaging), resting-state fMRI, and task-related fMRI.

次要结局

  • Depression, anxiety, and stress test(Baseline and 6 months)
  • Disability evaluation(Baseline and 6 months)
  • Cognitive flexibility test inside magnetic resonance imaging scanning(Baseline and 6 months)
  • Perseveration and abstract reasoning test outside magnetic resonance imaging scanning(Baseline and 6 months)
  • Working memory Test outside magnetic resonance imaging scanning(Baseline and 6 months)
  • Cognitive flexibility test outside magnetic resonance imaging scanning(Baseline and 6 months)
  • Inhibition test outside magnetic resonance imaging scanning(Baseline and 6 months)
  • Pain catastrophizing assessment(Baseline and 6 months)
  • Frailty status assessment(Baseline and 6 months)
  • Sleep quality assessment(Baseline and 6 months)
  • Cognitive function screening(Baseline and 6 months)
  • Balance, lower extremity strength and functional capacity assessment(Baseline and 6 months)
  • Mobility and balance assessment(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HSU Chun Liang

Assistant professor

The Hong Kong Polytechnic University

研究点 (1)

Loading locations...

相似试验