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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-85
SponsorThe Hong Kong Polytechnic University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Participants are not assigned an intervention

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Chronic non-specific low back pain group1 intervention
Group B: Healthy group1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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