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Clinical Trials/NCT07134699
NCT07134699RecruitingNot Applicable

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

The Hong Kong Polytechnic University1 site in 1 country60 target enrollmentStarted: May 6, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Pain intensity assessment

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
60 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Pain intensity assessment

Time Frame: Baseline and 6 months

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

Brain imaging

Time Frame: Baseline, 6 months

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

HSU Chun Liang

Assistant professor

The Hong Kong Polytechnic University

Study Sites (1)

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