Chronic Non-Specific Low Back PainNCT06704425
The Impacts of Chronic Non-specific Low Back Pain on Cognitive Functions of Older Adults
An observational study of Chronic Non-Specific Low Back Pain and Cognitive Decline, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
Trial 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. 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, Cross-Sectional Study
- What is being tested?
- For observational studies, participants are not assigned an intervention as part of the study.
- How many people
- 80 participants
- Where
- 3 sitesHong Kong
- Study dates
- 20 Apr 2024to 1 Nov 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
3 sites in 1 country.
Hong Kong3 sites, 3 recruiting
- Recruiting
University Research Facility in Behavioral and Systems Neuroscience
Hong Kong, Hong Kong, 999077
Celia DONG, PhD, +85227665384, mailcelia.dong@polyu.edu.hk
- Recruiting
Arnold YL Wong
Hong Kong, None Selected
Arnold YL Wong, 27666741, arnold.wong@polyu.edu.hk
- Recruiting
Department of Rehabilitation Sciences
Hong Kong, 999077
Arnold YL WONG, 85227666741, arnold.wong@polyu.edu.hk
About this study
Official title: 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.
- Conditions
- Chronic Non-Specific Low Back Pain, Cognitive Decline, Cross-Sectional Study, Older Adults, Brain Imaging
- Being tested
- For observational studies, participants are not assigned an intervention as part of the study.
- Keywords
- Chronic Non-Specific low back pain, cognitive decline, Cross-Sectional 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.
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.
| 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 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. Receives: 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. Receives: Other: For observational studies, participants are not assigned an intervention as part of the study. |
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
Secondary outcomes (15)
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
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
Working memory test inside magnetic resonance imaging scanning
The digit 2-back task, more response accuracy of digits indicates better working memory
Measured: 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
Measured: Baseline
Cognitive inhibition test inside magnetic resonance imaging scanning
Color-Word Matching Stroop Task, more correct matching indicate better ability to inhibit cognitive interference
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline
Inhibition test outside magnetic resonance imaging scanning
Go/NoGo task, more response accuracy indicates better control of inhibition.
Measured: 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.
Measured: Baseline
Pain drawing test
The body map scoring system indicates the location of participants' painful site
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start20 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion1 Nov 2025 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University
- Investigators
- Arnold YL Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704425
- Sponsor's protocol ID
- HSEARS20231212006
- Other IDs
- 1-CD63
- Status last verified
- Aug 2024
- First submitted
- 3 Jul 2024
- Last updated
- 26 Nov 2024
- 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 26 Nov 2024. 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 Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06704425
- Acronym / sponsor ID
- HSEARS20231212006
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 26 Nov 2024 (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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic non-specific low back pain group | – | Other: For observational studies, participants are not assigned an intervention as part of the study.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. |
| Healthy group | – | Other: For observational studies, participants are not assigned an intervention as part of the study.Healthy 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 |
|---|---|---|
| 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. | Other | Chronic non-specific low back pain group, Healthy group |
Primary outcome
Pain intensity assessment
Time frame: Baseline
11-point numerical rating scale, ranged from 0 to 10, higher scores indicate higher pain intensity.
15 secondary outcomes
Depression, anxiety, and stress test
Time frame: Baseline
Disability evaluation
Time frame: Baseline
Working memory test inside magnetic resonance imaging scanning
Time frame: Baseline
Cognitive flexibility test inside magnetic resonance imaging scanning
Time frame: Baseline
Cognitive inhibition test inside magnetic resonance imaging scanning
Time frame: Baseline
Perseveration and abstract reasoning test outside magnetic resonance imaging scanning
Time frame: Baseline
Working memory Test outside magnetic resonance imaging scanning
Time frame: Baseline
Cognitive flexibility test outside magnetic resonance imaging scanning
Time frame: Baseline
Inhibition test outside magnetic resonance imaging scanning
Time frame: Baseline
Pain catastrophizing assessment
Time frame: Baseline
Pain drawing test
Time frame: Baseline
Frailty status assessment
Time frame: Baseline
Physical activity assessment
Time frame: Baseline
Sleep quality assessment
Time frame: Baseline
Cognitive function screening
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- 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. This study is not recruiting at the moment.
Arnold YL Wong, PhD principal investigator
The Hong Kong Polytechnic University
3 sites 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 3 sites 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: status not confirmed, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank F Huang, MD (+85253037752, 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). 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 26 Nov 2024.