An observational study in Chronic Pain and Low Back Pain, sponsored by National Yang Ming Chiao Tung University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by National Yang Ming Chiao Tung University · Observational
The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 42 is below the median of 100 across 357 observational studies indexed under Back Pain.
Browse Back Pain studies →National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Population from community and local clinics will be selected.
Exclusion Criteria:
The participants whose low back pain intensity score ≥2 by numeric pain rating scale at 24-week follow-up.
The participants whose low back pain intensity score \<1 by numeric pain rating scale at 24-week follow-up.
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").
Time frame: 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").
Time frame: 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.
Time frame: 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").
Time frame: 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").
Time frame: at 24-week follow-up
Plan to share: No
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National Yang Ming Chiao Tung University