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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
The mechanical properties of chiropractic adjustment have been investigated; and although 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 consistent68 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
Mera Ghar Orphan House
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 repeated after 6 weeks of intervention.
Time frame: After 6 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 repeated after 12 weeks of intervention.
Time frame: After 12 weeks of intervention and 16 weeks (4-week follow-up testing in a sub-group of participants. )
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 repeated after 16 weeks of intervention.
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Time frame: After 16 weeks of intervention
Heart rate variability
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.
Time frame: Up to 16 Weeks
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 will be done before applying 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 repeated 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 repeated 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 repeated after 16 weeks of intervention.
Time frame: After 16 weeks of intervention
Spatial working memory (SWM)
Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as 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. Fewer errors mean good spatial working memory and vice versa for more errors. 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 notable executive function demands and provides a measure of strategy as well as 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. Fewer errors mean good spatial working memory and vice versa for more errors. Assessment of participants will be repeated 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 notable executive function demands and provides a measure of strategy as well as 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. Fewer errors mean good spatial working memory and vice versa for more errors. Assessment of participants will be repeated 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 notable executive function demands and provides a measure of strategy as well as 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. Fewer errors mean good spatial working memory and vice versa for more errors. Assessment of participants will be repeated 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. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. 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. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be repeated after 6 weeks of intervention.
Time frame: After 6 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. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be repeated 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. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time. Assessment of participants will be repeated 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. 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. Assessment of participants will be repeated 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. Assessment of participants will be repeated 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. Assessment of participants will be repeated after 16 weeks of intervention.
Time frame: After 16 weeks of intervention
Stockings of Cambridge (SoC)
Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. A baseline assessment of a participant will be done before the start of the intervention.
Time frame: At Baseline
Stockings of Cambridge (SoC)
Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. Assessment of participants will be repeated after 6 weeks of intervention.
Time frame: After 6 weeks of intervention
Stockings of Cambridge (SoC)
Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. Assessment of participants will be repeated after 12 weeks of intervention.
Time frame: After 12 weeks of intervention
Stockings of Cambridge (SoC)
Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. Assessment of participants will be repeated after 16 weeks of intervention.
Time frame: After 16 weeks of intervention
Delayed Matching to Sample (DMS)
Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. A baseline assessment of a participant will be done before the start of the intervention.
Time frame: At Baseline
Delayed Matching to Sample (DMS)
Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Assessment of participants will be repeated after 6 weeks of intervention.
Time frame: After 6 weeks of intervention
Delayed Matching to Sample (DMS)
Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Assessment of participants will be repeated after 12 weeks of intervention.
Time frame: After 12 weeks of intervention
Delayed Matching to Sample (DMS)
Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. Assessment of participants will be repeated 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 Pediatric v2.0 profile 25, 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. PROMIS Pediatric v2.0 profile 25 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. A baseline assessment of a participant will be done before the start of the intervention. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
Time frame: Base line
Health-related quality of life
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, 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. PROMIS Pediatric v2.0 profile 25 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. Assessment of participants will be repeated after 6 weeks of intervention. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
Time frame: After 6 weeks of intervention
Health-related quality of life
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, 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. PROMIS Pediatric v2.0 profile 25 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. Assessment of participants will be repeated after 12 weeks of intervention. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
Time frame: After 12 weeks of intervention
Health-related quality of life
The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, 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. PROMIS Pediatric v2.0 profile 25 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. Assessment of participants will be repeated after 16 weeks of intervention. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
Time frame: After 16 weeks of intervention