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Идёт набор NCT07134699

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

Наблюдательное Chronic Non-Specific Low Back Pain Cognitive Decline Longitudinal Study Older Adults

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Participants are not assigned an intervention.
Кому может быть актуально
Состояния в реестре: Chronic Non-Specific Low Back Pain, Cognitive Decline, Longitudinal Study, Older Adults. Базовые параметры: 60 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Другое Participants are not assigned an intervention
    For observational studies, participants are not assigned an intervention as part of the study.

Первичные конечные точки

  • Pain intensity assessment [Срок оценки: Baseline and 6 months]
  • Brain imaging [Срок оценки: Baseline, 6 months]
Вторичные конечные точки (12)
  • Depression, anxiety, and stress test [Срок оценки: Baseline and 6 months]
  • Disability evaluation [Срок оценки: Baseline and 6 months]
  • Cognitive flexibility test inside magnetic resonance imaging scanning [Срок оценки: Baseline and 6 months]
  • Perseveration and abstract reasoning test outside magnetic resonance imaging scanning [Срок оценки: Baseline and 6 months]
  • Working memory Test outside magnetic resonance imaging scanning [Срок оценки: Baseline and 6 months]
  • Cognitive flexibility test outside magnetic resonance imaging scanning [Срок оценки: Baseline and 6 months]
  • Inhibition test outside magnetic resonance imaging scanning [Срок оценки: Baseline and 6 months]
  • Pain catastrophizing assessment [Срок оценки: Baseline and 6 months]
  • Frailty status assessment [Срок оценки: Baseline and 6 months]
  • Sleep quality assessment [Срок оценки: Baseline and 6 months]
  • Cognitive function screening [Срок оценки: Baseline and 6 months]
  • Balance, lower extremity strength and functional capacity assessment [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Гонконг · 1 центр
  • Department of Rehabilitation Sciences — Гонконг

Идентификаторы

NCT: NCT07134699 · HSEARS20241003001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗