Clinical trial NCT06704425: The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults
Official title: The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Non-Specific Low Back Pain
Cognitive Decline
Cross-Sectional Study
Older Adults
Brain Imaging
Keywords: Chronic Non-Specific low back pain
cognitive decline
Cross-Sectional study
older adults
brain imaging
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic non-specific low back pain (CNSLBP) should have:

* CNSLBP that has lasted for at least 3 months, typically occurs in the area between the 12th rib to the iliac crest with and without leg pain and without a known pathoanatomical cause;
* an average pain intensity of ≥ 5 out of 10 on an 11-point numerical rating scale (NRS) in the last 7 days, where 0 means "no pain" and 10 means "worst pain imaginable"; and
* pain occurring more than 3 days per week. In addition, healthy controls should not have CNSLBP in the last 36 months.

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.


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

Primary outcomes:
measure: Pain intensity assessment
timeFrame: Baseline
Secondary outcomes:
measure: Depression, anxiety, and stress test
timeFrame: Baseline
measure: Disability evaluation
timeFrame: Baseline
measure: Working memory test inside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Cognitive flexibility test inside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Cognitive inhibition test inside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Working memory Test outside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Cognitive flexibility test outside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Inhibition test outside magnetic resonance imaging scanning
timeFrame: Baseline
measure: Pain catastrophizing assessment
timeFrame: Baseline
measure: Pain drawing test
timeFrame: Baseline
measure: Frailty status assessment
timeFrame: Baseline
measure: Physical activity assessment
timeFrame: Baseline
measure: Sleep quality assessment
timeFrame: Baseline
measure: Cognitive function screening
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Arnold YL Wong
state: None Selected
city: Hong Kong
country: Hong Kong
facility: Department of Rehabilitation Sciences
city: Hong Kong
country: Hong Kong
facility: University Research Facility in Behavioral and Systems Neuroscience
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arnold YL Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: