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Clinical Trials/NCT06704425
NCT06704425
Recruiting
Not Applicable

The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: a Cross-sectional Study

The Hong Kong Polytechnic University3 sites in 1 country80 target enrollmentApril 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Non-Specific Low Back Pain
Sponsor
The Hong Kong Polytechnic University
Enrollment
80
Locations
3
Primary Endpoint
Pain intensity assessment
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Chronic non-specific low back pain (CNSLBP) is a prevalent condition among older adult and has been associated with an increased risk of executive function impairment. Studies have shown that older adults with chronic pain are more likely to show poor cognitive performance than healthy controls. Cognitive performance is particularly important when managing pain in older adults, especially for some executive functions (e.g., inhibition, switching, working memory) because pain and executive functions have their bidirectional relationship. Further, executive dysfunctions are associated with a decline in functional status among older adults, particularly the impairment of instrumental activities of daily living. Given the above, the preservation of executive functions emerges as a pivotal consideration among old adults with CNSLBP. Studies have provided preliminary evidence of the correlation between brain changes associated with chronic pain and cognitive functions. For example, multisite chronic pain may contribute to an increased risk of cognitive decline via structural change in hippocampal atrophy. For another example, functional brain changes in chronic pain reduced the deactivation of several key default mode network regions, thereby predisposing individuals to cognitive impairments. Despite the aforementioned brain changes, no research has provided direct evidence to support the hypothesis that structural and functional brain changes caused by CNSLBP in older adults may be associated with cognitive decline. Specifically, whether CNSLBP may lead to structural changes (e.g., smaller 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) associated with cognitive decline remains unclear. With the help of neuroimaging, the knowledge about the underlying brain mechanisms between CNSLBP (chronic non-specific low back pain) and executive functions can be explained.

To gain a better 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. The results of this study have the potential to quantify the association between CNSLBP-related brain changes and executive functions in older adults, and provide insights into the development of new treatment strategies to improve or prevent executive function decline in older adults with CNSLBP.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
November 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Arnold Wong Yu Lok

Principal Investigator

The Hong Kong Polytechnic University

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

Outcomes

Primary Outcomes

Pain intensity assessment

Time Frame: Baseline

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

Secondary Outcomes

  • Depression, anxiety, and stress test(Baseline)
  • Disability evaluation(Baseline)
  • Working memory test inside magnetic resonance imaging scanning(Baseline)
  • Cognitive flexibility test inside magnetic resonance imaging scanning(Baseline)
  • Cognitive inhibition test inside magnetic resonance imaging scanning(Baseline)
  • Perseveration and abstract reasoning test outside magnetic resonance imaging scanning(Baseline)
  • Working memory Test outside magnetic resonance imaging scanning(Baseline)
  • Cognitive flexibility test outside magnetic resonance imaging scanning(Baseline)
  • Inhibition test outside magnetic resonance imaging scanning(Baseline)
  • Pain catastrophizing assessment(Baseline)
  • Pain drawing test(Baseline)
  • Frailty status assessment(Baseline)
  • Physical activity assessment(Baseline)
  • Sleep quality assessment(Baseline)
  • Cognitive function screening(Baseline)

Study Sites (3)

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