Menu
Recruiting NCT07134699

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Participants are not assigned an intervention.
Who it may be relevant to
Registry conditions: Chronic Non-Specific Low Back Pain, Cognitive Decline, Longitudinal Study, Older Adults. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Department of Rehabilitation Sciences — Hong Kong

Identifiers

NCT: NCT07134699 · HSEARS20241003001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗