The Effects of Chiropractic Care in Adults With Subclinical Spinal Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Subclinical Spinal Pain

Intervention / Treatment
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* Other: Chiropractic Care
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: research
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiropractic care Group<br>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. | Other: Chiropractic Care<br>* The actual force applied to the patient's spine depends on the chiropractor, the patient, and the spinal location of the subluxation, the general shape of the force-time history of spinal adjustments is very consistent and the duration of the thrust is always less than 200 milliseconds.<br>|
| Placebo Comparator: Control Group<br>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 | Other: Control Group<br>* 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 sham 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional near-infrared spectroscopy (fNIRS) | 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. | Base line | 
| Functional near-infrared spectroscopy (fNIRS) | 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. | After 6 weeks | 
| Functional near-infrared spectroscopy (fNIRS) | 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. | After 12 weeks of intervention | 
| Functional near-infrared spectroscopy (fNIRS) | 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. | Aftwe 16 weeks of intervention | 
| Heart rate variability (HRV) | 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. | Up to 16 weeks | 
| Serum Brain-derived neurotrophic factor (BDNF) | 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. | Base line | 
| Serum Brain-derived neurotrophic factor (BDNF) | 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. | After 12 weeks of intervention | 
| Serum Brain-derived neurotrophic factor (BDNF) | 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. | After 16 weeks of intervention | 
| Whole head EEG( sub-cohort of participants) | 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. | Base line | 
| Whole head EEG( sub-cohort of participants) | 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. | After 6 weeks of intervention | 
| Whole head EEG( sub-cohort of participants) | 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. | After 12 weeks of intervention | 
| Whole head EEG( sub-cohort of participants) | 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. | 16 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatial working memory (SWM) | Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has unique executive function demands and provides a measure of strategy and working memory error. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy. A baseline assessment of a participant will be done before the start of the intervention. | Base line | 
| Spatial working memory (SWM) | Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has unique executive function demands and provides a measure of strategy and working memory error. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy. Assessment of participants will be done after 6 weeks of intervention. | After 6 weeks of intervention | 
| Spatial working memory (SWM) | Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has unique executive function demands and provides a measure of strategy and working memory error. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy. Assessment of participants will be done after 12 weeks of intervention. | After 12 weeks of intervention | 
| Spatial working memory (SWM) | Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has unique executive function demands and provides a measure of strategy and working memory error. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy. Assessment of participants will be done after 16 weeks of intervention. | After 16 weeks of intervention | 
| Reaction time (RTI) | Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. More accurate reaction in less time inclines toward good reaction time. A baseline assessment of a participant will be done before the start of the intervention. | Base line | 
| Reaction time (RTI) | Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be done after 6 weeks of intervention. | After 6 weeks | 
| Reaction time (RTI) | Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. More accurate reaction in less time inclines towards good reaction time.Assessment of participants will be done after 12 weeks of intervention. | After 12 weeks of intervention | 
| Reaction time (RTI) | Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. More accurate reaction in less time inclines towards good reaction time.Assessment of participants will be done after 16 weeks of intervention. | After 16 weeks of intervention | 
| Paired Associate Learning (PAL) | Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Less errors made by participant shows good memory scores and PAL. A baseline assessment of a participant will be done before the start of the intervention. | Base line | 
| Paired Associate Learning (PAL) | Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Less errors made by participant shows good memory scores and PAL. Assessment of participants will be done after 6 weeks of intervention. | After 6 weeks of intervention | 
| Paired Associate Learning (PAL) | Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Less errors made by participant shows good memory scores and PAL.Assessment of participants will be done after 12 weeks of intervention. | After 12 weeks of intervention | 
| Paired Associate Learning (PAL) | Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Less errors made by participant shows good memory scores and PAL.Assessment of participants will be done after 16 weeks of intervention. | 16 weeks of intervention | 
| Stockings of Cambridge (SoC) | Stockings of Cambridge (SOC) is a spatial planning test that requires individuals to use problem-solving strategies to match two sets of stimuli Outcome measures include the problem difficulty level reached, mean moves used, and thinking time. more of the difficult level reached means participant is more competent and good at problem solving. | Base line | 
| Stockings of Cambridge (SoC) | Stockings of Cambridge (SOC) is a spatial planning test that requires individuals to use problem-solving strategies to match two sets of stimuli Outcome measures include the problem difficulty level reached, mean moves used, and thinking time. more of the difficult level reached means participant is more competent and good at problem solving.Assessment of participants will be done after 6 weeks of intervention. | After 6 weeks of intervention | 
| Stockings of Cambridge (SoC) | Stockings of Cambridge (SOC) is a spatial planning test that requires individuals to use problem-solving strategies to match two sets of stimuli Outcome measures include the problem difficulty level reached, mean moves used, and thinking time. more of the difficult level reached means participant is more competent and good at problem-solving.Assessment of participants will be done after 12 weeks of intervention. | After 12 weeks of intervention | 
| Stockings of Cambridge (SoC) | Stockings of Cambridge (SOC) is a spatial planning test that requires individuals to use problem-solving strategies to match two sets of stimuli Outcome measures include the problem difficulty level reached, mean moves used, and thinking time. more of the difficult level reached means participant is more competent and good at problem solving.Assessment of participants will be done after 16 weeks of intervention. | After 16 weeks of intervention | 
| Delayed Matching to Sample (DMS) | Delayed Matching to Sample assesses simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. A baseline assessment of a participant will be done before the start of the intervention. | Base line. | 
| Delayed Matching to Sample (DMS) | Delayed Matching to Sample assesses simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response.Assessment of participants will be done after 6 weeks of intervention. | After 6 weeks of intervention | 
| Delayed Matching to Sample (DMS) | Delayed Matching to Sample assesses simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response.Assessment of participants will be done after 12 weeks of intervention. | After 12 weeks of intervention | 
| Delayed Matching to Sample (DMS) | Delayed Matching to Sample assesses simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. Assessment of participants will be done after 16 weeks of intervention. | After 16 weeks of intervention | 
| Health-Related Quality of life | The health-related quality of life will be measured using the PROMIS-29 v2.0 profile, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The PROMIS-29 v2.0 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. | Baseline | 
| Health-Related Quality of life | The health-related quality of life will be measured using the PROMIS-29 v2.0 profile, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The PROMIS-29 v2.0 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. | After 6 weeks of intervention | 
| Health-Related Quality of life | The health-related quality of life will be measured using the PROMIS-29 v2.0 profile, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The PROMIS-29 v2.0 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. | After 12 weeks of intervention | 
| Health-Related Quality of life | The health-related quality of life will be measured using the PROMIS-29 v2.0 profile, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The PROMIS-29 v2.0 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. | After 16 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subclinical Spinal Pain