Chronic PainNCT05352594
The Brain Activity Changes in the Development of Chronic Low Back Pain
An observational study of Chronic Pain and Low Back Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Pain, Low Back Pain
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2022to Jul 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population from community and local clinics will be selected.
Who may be able to join
- Age≧ 20 y/o
- This is the 1st episode of low back pain in the past year
- Pain in the region of the lower back (bound by the thoracolumbar junction superiorly, and by the gluteal fold inferiorly)
- Pain duration < 12 weeks
- Average pain intensity in the past 7 days is ≧ 3/10 (Numeric Rating Scale)
- Mini-Mental State Examination ≧ 24
Who cannot join
- Pain onset duration < 7 days
- History of chronic pain
- Pain area other than the specify area
- Any systematic disease, fracture or cancer
- Present any neurological sign related to pain
- Infection
- Received any brain or spine surgeries, hip arthroplasty or any other kind of surgeries in the past 3 months
- Diagnosed with any neurological or psychological disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei, 112
Ray-Yau Wang, PhD, +886-2-28267210, rywang@nycu.edu.tw
About this study
Official title: The Brain Activity Changes in Persons With Low Back Pain: From Subacute to Chronic
The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.
Read the detailed description
Background and Purpose: Chronic low back pain (cLBP) is an adverse symptom not only to individuals but also to society. It impacts negatively on multiple aspects, such as physical activities, functional ability, quality of life and psychological status. Moreover, cLBP causes economic burden to both individuals and society. However, not all low back pain progresses to chronic condition. Cross-sectional studies have shown brain activated differently in people with cLBP as compared with healthy ones during rest and movement. In addition, lower cortical excitability or stronger functional connections between medial prefrontal cortex and nucleus accumbens were observed in those becoming cLBP according to previous longitudinal studies. Also, image studies have shown a shift in brain regions from pain related areas to those that control emotion and memory. According to these results, the brain activity is related to the persistence of pain. However, how brain activity changes during the chronicity of low back pain is still not fully understood. Therefore, the purpose of present study is to compare the brain changes in people with LBP with or without pain chronicity.
Methods: This is a longitudinal exploratory prospective study. Demographic data will be collected at baseline. The outcomes will be measured at entry of the study and at 24 weeks post-pain. Outcomes include pain intensity which is rated by Numerical rating scale(NRS), and brain activities which is recorded by electroencephalography (EEG) during resting and movement conditions.
Statistical analysis: According to the NRS at 6 month post-pain, the participants whose NRS sore ≥ 2 will be grouped in the cLBP group and those NRS ≤ 1 will be grouped in the recovered low back pain (rLBP) group. Two-way ANOVA with repeated-measures and Tukey's post hoc test will be used to analyze the differences between time and between groups. The changes of pain intensity during movement will be used as confounder for the analysis. Statistical significance is set at p<0.05.
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- Pain Chronicity, Low Back Pain, Electroencephalography, Brain Activity
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low Back Pain | The participants whose low back pain intensity score ≥2 by numeric pain rating scale at 24-week follow-up. | |
| Recovered Low Back Pain | The participants whose low back pain intensity score <1 by numeric pain rating scale at 24-week follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at the enrollment
The average pain intensity in the past week will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Measured: at the enrollment
Pain Intensity at 24-week follow-up
The average pain intensity in the past week will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Measured: at 24-week follow-up
Brain Activity Change from enrollment to 6-month follow-up
Participants' brain activity will be measured by electroencephalography (EEG) during functional reaching activity to assess the brain changes.
Measured: at the enrollment and 24-week follow-up
Pain intensity during functional reaching task at the enrollment
The pain intensity during functional reaching task will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Measured: at the enrollment
Pain intensity during functional reaching task at 24-week follow-up
The pain intensity during functional reaching task will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Measured: at 24-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start16 Sep 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray-Yau Wang, National Yang Ming Chiao Tung University
- Investigators
- Ray-Yau Wang, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352594
- Sponsor's protocol ID
- YM111017E
- Status last verified
- Sep 2022
- First submitted
- 18 Apr 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain Activity Changes in Persons With Low Back Pain: From Subacute to Chronic
- ClinicalTrials.gov ID
- NCT05352594
- Acronym / sponsor ID
- YM111017E
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- Pain Chronicity, Low Back Pain, Electroencephalography, Brain Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 29 Apr 2022 (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.
The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.
Detailed description
Background and Purpose: Chronic low back pain (cLBP) is an adverse symptom not only to individuals but also to society. It impacts negatively on multiple aspects, such as physical activities, functional ability, quality of life and psychological status. Moreover, cLBP causes economic burden to both individuals and society. However, not all low back pain progresses to chronic condition. Cross-sectional studies have shown brain activated differently in people with cLBP as compared with healthy ones during rest and movement. In addition, lower cortical excitability or stronger functional connections between medial prefrontal cortex and nucleus accumbens were observed in those becoming cLBP according to previous longitudinal studies. Also, image studies have shown a shift in brain regions from pain related areas to those that control emotion and memory. According to these results, the brain activity is related to the persistence of pain. However, how brain activity changes during the chronicity of low back pain is still not fully understood. Therefore, the purpose of present study is to compare the brain changes in people with LBP with or without pain chronicity.
Methods: This is a longitudinal exploratory prospective study. Demographic data will be collected at baseline. The outcomes will be measured at entry of the study and at 24 weeks post-pain. Outcomes include pain intensity which is rated by Numerical rating scale(NRS), and brain activities which is recorded by electroencephalography (EEG) during resting and movement conditions.
Statistical analysis: According to the NRS at 6 month post-pain, the participants whose NRS sore ≥ 2 will be grouped in the cLBP group and those NRS ≤ 1 will be grouped in the recovered low back pain (rLBP) group. Two-way ANOVA with repeated-measures and Tukey's post hoc test will be used to analyze the differences between time and between groups. The changes of pain intensity during movement will be used as confounder for the analysis. Statistical significance is set at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Low Back Pain | – | –The participants whose low back pain intensity score ≥2 by numeric pain rating scale at 24-week follow-up. |
| Recovered Low Back Pain | – | –The participants whose low back pain intensity score <1 by numeric pain rating scale at 24-week follow-up. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population from community and local clinics will be selected.
Key inclusion criteria (6 listed)
- Age≧ 20 y/o
- This is the 1st episode of low back pain in the past year
- Pain in the region of the lower back (bound by the thoracolumbar junction superiorly, and by the gluteal fold inferiorly)
- Pain duration < 12 weeks
- Average pain intensity in the past 7 days is ≧ 3/10 (Numeric Rating Scale)
Key exclusion criteria (8 listed)
- Pain onset duration < 7 days
- History of chronic pain
- Pain area other than the specify area
- Any systematic disease, fracture or cancer
- Present any neurological sign related to pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity at the enrollment
Time frame: at the enrollment
The average pain intensity in the past week will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Pain Intensity at 24-week follow-up
Time frame: at 24-week follow-up
The average pain intensity in the past week will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Brain Activity Change from enrollment to 6-month follow-up
Time frame: at the enrollment and 24-week follow-up
Participants' brain activity will be measured by electroencephalography (EEG) during functional reaching activity to assess the brain changes.
Pain intensity during functional reaching task at the enrollment
Time frame: at the enrollment
The pain intensity during functional reaching task will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Pain intensity during functional reaching task at 24-week follow-up
Time frame: at 24-week follow-up
The pain intensity during functional reaching task will be measured by numeric rating scale (NRS). NRS is a 11-point rating scale (0 represents "no pain" and 10 represents "worst pain imaginable").
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Ray-Yau Wang, PhD principal investigator
National Yang Ming Chiao Tung 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 Pain and Low Back Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 6 inclusion and 8 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 29 Sep 2022. 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 Taiwan. 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 Ray-Yau Wang, PhD (+886-2-2826-7210, rywang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity at the enrollment (time frame: at the enrollment). The study lists 5 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 29 Sep 2022.