Chronic Non-Specific Low Back PainNCT07134699
The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: A Longitudinal Study
An observational study of Chronic Non-Specific Low Back Pain and Cognitive Decline, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Non-Specific Low Back Pain, Cognitive Decline, Longitudinal Study
- What is being tested?
- Participants are not assigned an intervention
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 May 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chun Liang HSU, PhD contact
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Sciences
Hong Kong, 999077
Chun Liang Hsu, PhD, 852-2766-6755, chun-liang.hsu@polyu.edu.hk
About this study
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
- Being tested
- Participants are not assigned an intervention
- Keywords
- Chronic Non-Specific low back pain, Cognitive decline, longitudinal study, older adults, brain imaging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are not assigned an interventionOther
For observational studies, participants are not assigned an intervention as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Participants are not assigned an intervention | |
| Healthy group | Healthy controls should not have CNSLBP in the last 36 months. Receives: Other: Participants are not assigned an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessment
11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
Measured: 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.
Measured: Baseline, 6 months
Secondary outcomes (13)
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
Inhibition test outside magnetic resonance imaging scanning
Go/NoGo task, more response accuracy indicates better control of inhibition.
Measured: Baseline and 6 months
Pain catastrophizing assessment
The Chinese version of Pain Catastrophizing Score. The scores ranged from 0 to 13, higher scores indicate more pain catatrophizing thought.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
Balance, lower extremity strength and functional capacity assessment
Short Physical Performance Battery (SPPB). It consists of three components: balance test, gait speed test, and chair stand test. The SPPB scores range from 0 to 12. Individuals with SPPB scores between 10 and 12 can exercise at home and in the community while those with more severe mobility limitations (scores < 10) require further assessment and supervision for exercise.
Measured: Baseline and 6 months
Mobility and balance assessment
Timed Up and Go (TUG) test. It measures the time taken for an individual to rise from a chair, walk 3 meters, turn around, walk back, and sit down again. The TUG test helps identify individuals at risk of falls and mobility impairments. A shorter completion time indicates a better balance and functional mobility.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start6 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HSU Chun Liang, The Hong Kong Polytechnic University
- Investigators
- Chun Liang Hsu, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134699
- Sponsor's protocol ID
- HSEARS20241003001
- Status last verified
- May 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07134699
- Acronym / sponsor ID
- HSEARS20241003001
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic non-specific low back pain group | – | Other: Participants are not assigned an interventionParticipants 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. |
| Healthy group | – | Other: Participants are not assigned an interventionHealthy controls should not have CNSLBP in the last 36 months. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants are not assigned an interventionFor observational studies, participants are not assigned an intervention as part of the study. | Other | Chronic non-specific low back pain group, Healthy group |
Primary outcome
Pain intensity assessment
Time frame: Baseline and 6 months
11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
Brain imaging
Time frame: Baseline, 6 months
Perform the following MRI sequences: T1-weighted, T2-weighted, DTI (diffusion tensor imaging), resting-state fMRI, and task-related fMRI.
13 secondary outcomes
Depression, anxiety, and stress test
Time frame: Baseline and 6 months
Disability evaluation
Time frame: Baseline and 6 months
Cognitive flexibility test inside magnetic resonance imaging scanning
Time frame: Baseline and 6 months
Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
Time frame: Baseline and 6 months
Working memory Test outside magnetic resonance imaging scanning
Time frame: Baseline and 6 months
Cognitive flexibility test outside magnetic resonance imaging scanning
Time frame: Baseline and 6 months
Inhibition test outside magnetic resonance imaging scanning
Time frame: Baseline and 6 months
Pain catastrophizing assessment
Time frame: Baseline and 6 months
Frailty status assessment
Time frame: Baseline and 6 months
Sleep quality assessment
Time frame: Baseline and 6 months
Cognitive function screening
Time frame: Baseline and 6 months
Balance, lower extremity strength and functional capacity assessment
Time frame: Baseline and 6 months
Mobility and balance assessment
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun Liang HSU, PhD contact
Chun Liang Hsu, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Non-Specific Low Back Pain and Cognitive Decline, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank F Huang, MD (852-5303-7752, fan2023.huang@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessment (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.