The Effects of Chiropractic Care on Neurophysiological Function Immune Markers and Health Related Quality of Life in Children With Subclinical Spinal Pain Using Artificial Intelligence Modelling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Functional near-infrared spectroscopy (fNIRS)
研究概览
简要总结
There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function.This study aims to investigate short term and long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in children with subclinical spinal pain.
详细描述
There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function. A single chiropractic adjustment session has been shown to alter pre-frontal cortex (PFC) activity in adults, but there is a lack of robust research investigating any long-term benefits of such PFC changes in children. This study aims to investigate short term and long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in children with subclinical spinal pain. In this parallel-group randomized controlled trial, participants aged 10-18 years with subclinical spinal pain will be randomly allocated to receive either 12 weeks of CC intervention or control intervention. Primary outcomes include functional near-infrared spectroscopy, heart rate variability (HRV) and resting-state electroencephalography (EEG). The secondary outcomes include executive functions measured by cognitive testing, immune and inflammation status, and health-related quality of life. As data collected in the project is the combination of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV etc.), we will utilize the advances in machine learning or artificial intelligence (AI) to help inform the development of optimal chiropractic care plans in future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 10 and 18 years
- •have subclinical spinal pain
排除标准
- •no evidence of spinal dysfunction is present
- •they are in current pain (above 3/10 on VAS)
- •have sought previous treatment for their spinal issues
- •are unable to perform the assessment procedures due to contraindications or movement limitations
- •diagnosed immune dysfunction
- •utilizing a prescribed immunosuppressive medication
- •have uncontrolled asthma
- •nasal polyps
- •use of an intranasal steroid spray one month or less before the study
- •are HIV-positive
- •are participating in another research study at the time of data collection
- •have any diagnosed comorbidity or concomitant disease
- •have allergies to yeast or yeast-derived products
- •have chronic sinusitis or recent (within the last six weeks) episode of acute sinusitis.
结局指标
主要结局
Functional near-infrared spectroscopy (fNIRS)
时间窗: After 16 weeks of intervention
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks (Cognitive tasks). Assessment of participants will be repeated after 16 weeks of intervention.
Whole head EEG(sub-cohort of participants)
时间窗: After 16 weeks of intervention
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention. Assessment of participants will be repeated after 16 weeks of intervention.
Heart rate variability
时间窗: Up to 16 Weeks
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention.
次要结局
- Spatial working memory (SWM)(After 16 weeks of intervention)
- Reaction time (RTI)(After 16 weeks of intervention)
- Stockings of Cambridge (SoC)(After 16 weeks of intervention)
- Delayed Matching to Sample (DMS)(After 16 weeks of intervention)
- Paired Associate Learning (PAL)(After 16 weeks of intervention)
- Health-related quality of life(After 16 weeks of intervention)