The Effects of Chiropractic Care on Neurophysiological Function, Immune Markers and Health-Related Quality of Life in Adults With Subclinical Spinal Pain Using AI Modelling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Heart rate variability (HRV)
研究概览
简要总结
This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical 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 session of chiropractic adjustment has shown to alter pre-frontal cortex (PFC) activity, but there is a lack of robust research investigating the long-term benefits of such PFC changes. This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical pain. In these parallel-group randomized controlled trials, participants aged 18-60 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), serum Brain-Derived Neurotrophic Factors (BDNF) levels and resting-state electroencephalography (EEG). The secondary outcomes include PFC activity (measured by cognitive and behavioral testing), immune and inflammatory markers and health-related quality of life. As data collected in the project is a combination of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV etc.), the machine learning or artificial intelligence (AI) will be used to help 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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 60 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
- •they have uncontrolled asthma
- •have nasal polyps
- •use of an intranasal steroid spray one month or less before the study
- •are HIV-positive
- •unable or unwilling to comply with the study protocol
- •a history of drug abuse
- •are participating in another research study during the time of data collection.
- •have any diagnosed comorbidity or concomitant disease
- •donated blood within last month
- •have allergies to yeast or yeast-derived products
- •have chronic sinusitis and/ or recent (within the last six weeks) episodes of acute sinusitis.
结局指标
主要结局
Heart rate variability (HRV)
时间窗: Up to 16 weeks
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.
Serum Brain-derived neurotrophic factor (BDNF)
时间窗: After 16 weeks of intervention
Brain-derived neurotrophic factor (BDNF) plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, essential for learning and memory. The higher concentration shows more activity. Assessment of participants will be done after 16 weeks of intervention.
Whole head EEG( sub-cohort of participants)
时间窗: 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 done after 16 weeks of intervention.
Functional near-infrared spectroscopy (fNIRS)
时间窗: Aftwe 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 done after 16 weeks of intervention.
次要结局
- Health-Related Quality of life(After 16 weeks of intervention)
- Spatial working memory (SWM)(After 16 weeks of intervention)
- Paired Associate Learning (PAL)(16 weeks of intervention)
- Stockings of Cambridge (SoC)(After 16 weeks of intervention)
- Delayed Matching to Sample (DMS)(After 16 weeks of intervention)
- Reaction time (RTI)(After 16 weeks of intervention)