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

NCT07134699 | Recruiting

• 1 other identifier: HSEARS20241003001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Non-Specific Low Back Pain; Cognitive Decline; Longitudinal Study; Older Adults; Brain Imaging

Keywords

Chronic Non-Specific low back pain; Cognitive decline; longitudinal study; older adults; brain imaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Depression, anxiety, and stress test

  Baseline and 6 months

• Disability evaluation

  Baseline and 6 months

• Cognitive flexibility test inside magnetic resonance imaging scanning

  Baseline and 6 months

• Perseveration and abstract reasoning test outside magnetic resonance imaging scanning

  Baseline and 6 months

• Working memory Test outside magnetic resonance imaging scanning

  Baseline and 6 months

Study Arms (2)

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

Healthy group

Healthy controls should not have CNSLBP in the last 36 months.

Other: Participants are not assigned an intervention

Interventions

Participants are not assigned an intervention OTHER

For observational studies, participants are not assigned an intervention as part of the study.

Chronic non-specific low back pain group; Healthy group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Department of Rehabilitation Sciences

Hong Kong, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chun Liang Hsu, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank F Huang, MD

CONTACT

852-5303-7752; fan2023.huang@connect.polyu.hk

Chun Liang HSU, PhD

CONTACT

chun-liang.hsu@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-05

Locations

HK (1)