An observational study in Chronic Non-Specific Low Back Pain, Cognitive Decline and Cross-Sectional Study, sponsored by The Hong Kong Polytechnic University. Recruiting at 3 sites in Hong Kong. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by The Hong Kong Polytechnic University · Observational
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 357 observational studies indexed under Back Pain.
Browse Back Pain studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Participants with chronic non-specific low back pain (CNSLBP) should have:
Exclusion Criteria:
Participants with chronic non-specific low back pain (CNSLBP) should have: (1) 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; (2) 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 (3) pain occurring more than 3 days per week.
Other: For observational studies, participants are not assigned an intervention as part of the study.
Healthy controls should not have CNSLBP in the last 36 months.
Other: For observational studies, participants are not assigned an intervention as part of the study.
For observational studies, participants are not assigned an intervention as part of the study.
Pain intensity assessment
11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
Time frame: Baseline
Depression, anxiety, and stress test
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.
Time frame: Baseline
Disability evaluation
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.
Time frame: Baseline
Working memory test inside magnetic resonance imaging scanning
The digit 2-back task, more response accuracy of digits indicates better working memory
Time frame: Baseline
Cognitive flexibility test inside magnetic resonance imaging scanning
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
Time frame: Baseline
Cognitive inhibition test inside magnetic resonance imaging scanning
Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference
Time frame: Baseline
Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
The Modified Wisconsin Card Sorting Test, more correct matching of cards indicate better perseveration and abstract reasoning.
Time frame: Baseline
Working memory Test outside magnetic resonance imaging scanning
The Verbal Digits Forward and Backward Test, more correct recall of digits indicate better working memory and executive function
Time frame: Baseline
Cognitive flexibility test outside magnetic resonance imaging scanning
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
Time frame: Baseline
Inhibition test outside magnetic resonance imaging scanning
Go/NoGo task, more response accuracy indicates better control of inhibition.
Time frame: Baseline
Pain catastrophizing assessment
The Chinese version of Pain Catastrophizing Score. The scores ranged from 0 to 13, higher scores indicate more pain catatrophizing thought.
Time frame: Baseline
Pain drawing test
The body map scoring system indicates the location of participants' painful site
Time frame: Baseline
Frailty status assessment
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.
Time frame: Baseline
Physical activity assessment
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.
Time frame: Baseline
Sleep quality assessment
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.
Time frame: Baseline
Cognitive function screening
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.
Time frame: Baseline
Plan to share: Undecided
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The Hong Kong Polytechnic University