The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults

The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: a Cross-sectional Study

Chronic non-specific low back pain (CNSLBP) is a prevalent condition among older adult and has been associated with an increased risk of executive function impairment. Studies have shown that older adults with chronic pain are more likely to show poor cognitive performance than healthy controls. Cognitive performance is particularly important when managing pain in older adults, especially for some executive functions (e.g., inhibition, switching, working memory) because pain and executive functions have their bidirectional relationship. Further, executive dysfunctions are associated with a decline in functional status among older adults, particularly the impairment of instrumental activities of daily living. Given the above, the preservation of executive functions emerges as a pivotal consideration among old adults with CNSLBP. Studies have provided preliminary evidence of the correlation between brain changes associated with chronic pain and cognitive functions. For example, multisite chronic pain may contribute to an increased risk of cognitive decline via structural change in hippocampal atrophy. For another example, functional brain changes in chronic pain reduced the deactivation of several key default mode network regions, thereby predisposing individuals to cognitive impairments. Despite the aforementioned brain changes, no research has provided direct evidence to support the hypothesis that structural and functional brain changes caused by CNSLBP in older adults may be associated with cognitive decline. Specifically, whether CNSLBP may lead to structural changes (e.g., smaller 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) associated with cognitive decline remains unclear. With the help of neuroimaging, the knowledge about the underlying brain mechanisms between CNSLBP (chronic non-specific low back pain) and executive functions can be explained.

To gain a better 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. The results of this study have the potential to quantify the association between CNSLBP-related brain changes and executive functions in older adults, and provide 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; Cross-Sectional Study
• Intervention / Treatment: Other: For observational studies, participants are not assigned an intervention as part of the study.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Frank F Huang, MD; Phone Number: +85253037752; Email: fan2023.huang@connect.polyu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Department of Rehabilitation Sciences
    • Contact: Arnold YL WONG; Phone Number: 85227666741; Email: arnold.wong@polyu.edu.hk
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • University Research Facility in Behavioral and Systems Neuroscience
    • Contact: Celia DONG, PhD; Phone Number: +85227665384; Email: mailcelia.dong@polyu.edu.hk
  • None Selected
    • Hong Kong, None Selected, Hong Kong
      • Recruiting
      • Arnold YL Wong
      • Contact: Arnold YL Wong; Phone Number: 27666741; Email: arnold.wong@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
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 with and without 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: For observational studies, participants are not assigned an intervention as part of the study.; For observational studies, participants are not assigned an intervention as part of the study.
Healthy group; Healthy controls should not have CNSLBP in the last 36 months.	Other: For observational studies, participants are not assigned an intervention as part of the study.; 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

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
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
Working memory test inside magnetic resonance imaging scanning	The digit 2-back task, more response accuracy of digits indicates better working memory	Baseline
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
Cognitive inhibition test inside magnetic resonance imaging scanning	Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference	Baseline
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
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
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
Inhibition test outside magnetic resonance imaging scanning	Go/NoGo task, more response accuracy indicates better control of inhibition.	Baseline
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
Pain drawing test	The body map scoring system indicates the location of participants' painful site	Baseline
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
Physical activity assessment	Physical Activity Scale for the Elderly; it has 3 domains (leisure, household, and occupation activities) to measure physical activity levels of adults aged 65 or above. higher scores indicate more active.	Baseline
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
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Arnold YL Wong, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: older adults; cognitive decline; brain imaging; Chronic Non-Specific low back pain; Cross-Sectional study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Back Pain; Cognitive Dysfunction; Low Back Pain
• Other Study ID Numbers: HSEARS20231212006; 1-CD63 (Other Grant/Funding Number: Reserach Center of Smart Aging)

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
• product manufactured in and exported from the U.S.: No