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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
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
Railway General Hospital
Rawalpindi, Pakistan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 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. A baseline assessment of a participant will be done before the start of the intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 16 weeks of intervention