The Brain Activity Changes in the Development of Chronic Low Back Pain

Status Recruiting

Clinical Trial Summary

The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05352594
Study type	Observational
Source	National Yang Ming University
Contact	Ray-Yau Wang, PhD
Phone	+886-2-2826-7210
Email	rywang@nycu.edu.tw
Status	Recruiting
Phase
Start date	September 16, 2022
Completion date	July 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.