The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: A Longitudinal Study

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults; Cognitive Decline; Brain Imaging; Chronic Non-Specific Low Back Pain; Longitudinal Study
• Intervention / Treatment: Other: Participants are not assigned an intervention

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Frank F Huang, MD; Phone Number: 852-5303-7752; Email: fan2023.huang@connect.polyu.hk
• Study Contact Backup: Name: Chun Liang HSU, PhD; Email: chun-liang.hsu@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Department of Rehabilitation Sciences
    • Contact: Chun Liang Hsu, PhD; Phone Number: 852-2766-6755; Email: chun-liang.hsu@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy group; 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.
Chronic non-specific low back pain group; 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; For observational studies, participants are not assigned an intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity assessment	11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.	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.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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	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.	Baseline and 6 months
Inhibition test outside magnetic resonance imaging scanning	Go/NoGo task, more response accuracy indicates better control of inhibition.	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.	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.	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.	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.	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.	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.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Chun Liang HSU, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: August 14, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive decline; older adults; longitudinal study; brain imaging; Chronic Non-Specific low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Back Pain; Cognitive Dysfunction; Low Back Pain
• Other Study ID Numbers: HSEARS20241003001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No