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

NCT06704425 | Recruiting

• 2 other identifiers: HSEARS202312120061-CD63
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

Chronic Non-Specific low back pain; cognitive decline; Cross-Sectional study; older adults; brain imaging

Outcome Measures

Primary Outcomes (1)

• Pain intensity assessment

  11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.

  Baseline

Secondary Outcomes (15)

• Depression, anxiety, and stress test

  Baseline

• Disability evaluation

  Baseline

• Working memory test inside magnetic resonance imaging scanning

  Baseline

• Cognitive flexibility test inside magnetic resonance imaging scanning

  Baseline

• Cognitive inhibition test inside magnetic resonance imaging scanning

  Baseline

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 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.

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.

Interventions

For observational studies, participants are not assigned an intervention as part of the study. 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 (3)

University Research Facility in Behavioral and Systems Neuroscience

Hong Kong, Hong Kong, 999077, Hong Kong

RECRUITING

Arnold YL Wong

Hong Kong, None Selected, Hong Kong

RECRUITING

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

• Arnold YL Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank F Huang, MD

CONTACT

+85253037752; fan2023.huang@connect.polyu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: November 26, 2024
• Study Start: April 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: November 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-08

Locations

HK (3)