NCT07134699 The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: A Longitudinal Study
| NCT ID | NCT07134699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Chronic Non-Specific Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-05-06 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Chun Liang Hsu, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT07134699 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Chronic Non-Specific Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07134699 currently recruiting?
Yes, NCT07134699 is actively recruiting participants. Contact the research team at fan2023.huang@connect.polyu.hk for enrollment information.
Where is the NCT07134699 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07134699 clinical trial?
NCT07134699 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Chun Liang Hsu, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 60 participants.