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

NCT ID: NCT06704425

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-11-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

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

Intervention Type: 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.

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

Intervention Type: 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.

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Arnold Wong Yu Lok

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnold YL Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

University Research Facility in Behavioral and Systems Neuroscience

Hong Kong, Hong Kong, Hong Kong

Site Status: RECRUITING

Arnold YL Wong

Hong Kong, None Selected, Hong Kong

Site Status: RECRUITING

Department of Rehabilitation Sciences

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Frank F Huang, MD

Role: CONTACT

fan2023.huang@connect.polyu.hk

+85253037752

Facility Contacts

Celia DONG, PhD

Role: primary

mailcelia.dong@polyu.edu.hk

+85227665384

Arnold YL Wong

Role: primary

arnold.wong@polyu.edu.hk

27666741

Arnold YL WONG

Role: primary

arnold.wong@polyu.edu.hk

85227666741

Other Identifiers

1-CD63

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSEARS20231212006

Identifier Type: -

Identifier Source: org_study_id