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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Heart rate variability (HRV)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged between 18 and 60 years
- •have subclinical spinal pain
Exclusion Criteria
- •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.
Arms & Interventions
Chiropractic care Group
A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor with at least five years of clinical experience.The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. Chiropractors use these biomechanical characteristics as clinical indicators of spinal dysfunction and vertebral subluxation.
Intervention: Chiropractic Care (Other)
Control Group
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The control intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust. No spinal adjustment will be performed during any control intervention. This control intervention is not intended to act as a sham treatment session
Intervention: Control Group (Other)
Outcomes
Primary Outcomes
Heart rate variability (HRV)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Functional near-infrared spectroscopy (fNIRS)
Time Frame: Base line
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). A baseline assessment of a participant will be done before the start of the intervention.
Functional near-infrared spectroscopy (fNIRS)
Time Frame: After 6 weeks
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 6 weeks of intervention.
Functional near-infrared spectroscopy (fNIRS)
Time Frame: After 12 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 12 weeks of intervention.
Serum Brain-derived neurotrophic factor (BDNF)
Time Frame: Base line
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. A baseline assessment of a participant will be done before the start of the intervention.
Serum Brain-derived neurotrophic factor (BDNF)
Time Frame: After 12 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 12 weeks of intervention.
Whole head EEG( sub-cohort of participants)
Time Frame: Base line
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. A baseline assessment of a participant will be done before the start of the intervention.
Whole head EEG( sub-cohort of participants)
Time Frame: After 6 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 6 weeks of intervention.
Whole head EEG( sub-cohort of participants)
Time Frame: After 12 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 12 weeks of intervention.
Secondary Outcomes
- 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)
- Spatial working memory (SWM)(Base line)
- Spatial working memory (SWM)(After 6 weeks of intervention)
- Spatial working memory (SWM)(After 12 weeks of intervention)
- Reaction time (RTI)(Base line)
- Reaction time (RTI)(After 6 weeks)
- Reaction time (RTI)(After 12 weeks of intervention)
- Paired Associate Learning (PAL)(Base line)
- Paired Associate Learning (PAL)(After 6 weeks of intervention)
- Paired Associate Learning (PAL)(After 12 weeks of intervention)
- Stockings of Cambridge (SoC)(Base line)
- Stockings of Cambridge (SoC)(After 6 weeks of intervention)
- Stockings of Cambridge (SoC)(After 12 weeks of intervention)
- Delayed Matching to Sample (DMS)(Base line.)
- Delayed Matching to Sample (DMS)(After 6 weeks of intervention)
- Delayed Matching to Sample (DMS)(After 12 weeks of intervention)
- Health-Related Quality of life(Baseline)
- Health-Related Quality of life(After 6 weeks of intervention)
- Health-Related Quality of life(After 12 weeks of intervention)