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NCT Number: NCT06704425

The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Research Facility in Behavioral and Systems Neuroscience, Hong Kong

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Pain intensity assessment

    Time frame: Baseline

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

Secondary outcomes

  1. Depression, anxiety, and stress test

    Time frame: Baseline

    The Chinese version of the short Depression Anxiety Stress Scales, scores ranged from 0 to 13, higher scores for each domain (depression, anxiety, and stress) indicate more respective problems.

  2. Disability evaluation

    Time frame: Baseline

    The Hong Kong Chinese Version of the Roland-Morris Disability Questionnaire has 24 items. Scores ranged from 0 to 24, higher scores indicate worse disability.

  3. Working memory test inside magnetic resonance imaging scanning

    Time frame: Baseline

    The digit 2-back task, more response accuracy of digits indicates better working memory

  4. Cognitive flexibility test inside magnetic resonance imaging scanning

    Time frame: Baseline

    The More Odd Shifting task, It requires participants to switch between different mental sets or rules, such as identifying odd numbers or shifting between different categories. Better response accuracy indicates better cognitive flexibility

  5. Cognitive inhibition test inside magnetic resonance imaging scanning

    Time frame: Baseline

    Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference

  6. Perseveration and abstract reasoning test outside magnetic resonance imaging scanning

    Time frame: Baseline

    The Modified Wisconsin Card Sorting Test, more correct matching of cards indicate better perseveration and abstract reasoning.

  7. Working memory Test outside magnetic resonance imaging scanning

    Time frame: Baseline

    The Verbal Digits Forward and Backward Test, more correct recall of digits indicate better working memory and executive function

  8. Cognitive flexibility test outside magnetic resonance imaging scanning

    Time frame: Baseline

    The Trail Making Tests, a neuropsychological test of visual attention and task switching, completing the trail correctly within a shorter period of time means better cognitive flexibility

  9. Inhibition test outside magnetic resonance imaging scanning

    Time frame: Baseline

    Go/NoGo task, more response accuracy indicates better control of inhibition.

  10. Pain catastrophizing assessment

    Time frame: Baseline

    The Chinese version of Pain Catastrophizing Score. The scores ranged from 0 to 13, higher scores indicate more pain catatrophizing thought.

  11. Pain drawing test

    Time frame: Baseline

    The body map scoring system indicates the location of participants' painful site

  12. Frailty status assessment

    Time frame: Baseline

    Fatigue, Resistance, Ambulation, Illness, and Loss, the presence of 3 of 5 item characteristics indicate the presence of frailty, scores ranged from 0 to 5. Lower scores mean more frailty.

  13. Physical activity assessment

    Time frame: Baseline

    Physical Activity Scale for the Elderly; it has 3 domains (leisure, household, and occupation activities) to measure physical activity levels of adults aged 65 or above. higher scores indicate more active.

  14. Sleep quality assessment

    Time frame: Baseline

    Pittsburgh Sleep Quality Index. It has 7 domains to measure sleep quality , sleep latency, sleep duration, habital sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Scores ranged from 0 to 21, higher scores indicate poorer sleep quality.

  15. Cognitive function screening

    Time frame: Baseline

    Hong Kong Montreal Cognitive Assessment. It is a cognitive screening tool specifically adapted for Chinese older adults in Hong Kong. It is designed to detect mild cognitive impairment and dementia. A score < 26 suggests participant has mild cognitive impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Frank F Huang, MD

CONTACT

[email protected]

+85253037752

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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