An observational study in Chronic Non-Specific Low Back Pain, Cognitive Decline and Longitudinal Study, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by The Hong Kong Polytechnic University · Observational
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction 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 may or may not accompanied by 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: Participants are not assigned an intervention
Healthy controls should not have CNSLBP in the last 36 months.
Other: Participants are not assigned an intervention
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 and 6 months
Brain imaging
Perform the following MRI sequences: T1-weighted, T2-weighted, DTI (diffusion tensor imaging), resting-state fMRI, and task-related fMRI.
Time frame: Baseline, 6 months
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 and 6 months
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 and 6 months
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 and 6 months
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 and 6 months
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 and 6 months
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 and 6 months
Inhibition test outside magnetic resonance imaging scanning
Go/NoGo task, more response accuracy indicates better control of inhibition.
Time frame: Baseline and 6 months
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 and 6 months
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 and 6 months
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 and 6 months
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 and 6 months
Balance, lower extremity strength and functional capacity assessment
Short Physical Performance Battery (SPPB). It consists of three components: balance test, gait speed test, and chair stand test. The SPPB scores range from 0 to 12. Individuals with SPPB scores between 10 and 12 can exercise at home and in the community while those with more severe mobility limitations (scores \< 10) require further assessment and supervision for exercise.
Time frame: Baseline and 6 months
Mobility and balance assessment
Timed Up and Go (TUG) test. It measures the time taken for an individual to rise from a chair, walk 3 meters, turn around, walk back, and sit down again. The TUG test helps identify individuals at risk of falls and mobility impairments. A shorter completion time indicates a better balance and functional mobility.
Time frame: Baseline and 6 months
Plan to share: Undecided
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The Hong Kong Polytechnic University