The Brain Activity Changes in the Development of Chronic Low Back Pain
NCT ID: NCT05352594
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
42 participants
OBSERVATIONAL
2022-09-16
2023-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic Low Back Pain
The participants whose low back pain intensity score ≥2 by numeric pain rating scale at 24-week follow-up.
No interventions assigned to this group
Recovered Low Back Pain
The participants whose low back pain intensity score \<1 by numeric pain rating scale at 24-week follow-up.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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National Yang Ming Chiao Tung University
OTHER
Responsible Party
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Ray-Yau Wang
Professor
Principal Investigators
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Ray-Yau Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
National Yang Ming Chiao Tung University
Locations
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National Yang Ming Chiao Tung University
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YM111017E
Identifier Type: -
Identifier Source: org_study_id
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