Department of Rehabilitation Sciences
Hong Kong, 999077
Location status: Recruiting
NCT Number: NCT07134699
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.
Interested in participating?
Request Info60 year–85 year
All sexes
Observational
Hong Kong, 999077
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For observational studies, participants are not assigned an intervention as part of the study.
Time frame: Baseline and 6 months
11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
Time frame: Baseline, 6 months
Perform the following MRI sequences: T1-weighted, T2-weighted, DTI (diffusion tensor imaging), resting-state fMRI, and task-related fMRI.
Time frame: Baseline and 6 months
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
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
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
The Modified Wisconsin Card Sorting Test, more correct matching of cards indicate better perseveration and abstract reasoning.
Time frame: Baseline and 6 months
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
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
Go/NoGo task, more response accuracy indicates better control of inhibition.
Time frame: Baseline and 6 months
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Chun Liang HSU, PhD
CONTACT
Frank F Huang, MD
CONTACT
The Hong Kong Polytechnic University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT06704425
Brain Imaging, Chronic Non-Specific Low Back Pain
Hong Kong
View Trial DetailsNCT07724704
Chronic Non-Specific Low Back Pain, Neurologic Manifestations
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07636967
Chronic Non-Specific Low Back Pain
Tanta, Gharbia Governorate, Egypt
View Trial DetailsNCT07645859
Chronic Non-Specific Low Back Pain
Karachi, Pakistan
View Trial Details