The Effects of Chiropractic Care in Adults With Subclinical Spinal Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Subclinical Spinal Pain
• Intervention / Treatment: Other: Control Group; Other: Chiropractic Care

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Rawalpindi, Pakistan
    • Railway General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Chiropractic Care; 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.
Placebo Comparator: 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	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 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smartphone Gait and Balance Application	The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline.	Baseline
Immune Function Questionnaire (IFQ)	The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and extended healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. A baseline assessment of a participant will be done before the start of the intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.	Base line
Immune Function Questionnaire (IFQ)	The IFQ consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and extended healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be done after 6 weeks of intervention.Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.	After 6 weeks of intervention
Immune Function Questionnaire (IFQ)	The IFQ consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and extended healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be done after 12 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.	After 12 weeks of intervention
Immune Function Questionnaire (IFQ)	The IFQ consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and extended healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be done after 16 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status.	After 16 weeks of intervention
Inflammation markers from Fitbit data	Fitbit can be used to measure the autonomic nervous system (ANS). Heart rate variability (HRV) has become a validated marker of autonomic function. In a large population-based study it was found that strong and independent relationships between HR and HRV with a broad set of inflammatory biomarkers. The recording will be done for up to 16 weeks.	Up to 16 weeks
Pittsburgh Sleep Quality Index (PSQI)	Sleep is also an important determinant of health in general and specifically for stress. PSQI is a reliable self-reported questionnaire to examine the course and natural history of sleep over a 1-month time interval.89 Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as the global score) indicating worse sleep quality. A baseline assessment of a participant will be done before the start of the intervention.	Base line
Pittsburgh Sleep Quality Index (PSQI)	Sleep is also an important determinant of health in general and specifically for stress. PSQI is a reliable self-reported questionnaire to examine the course and natural history of sleep over a 1-month time interval.89 Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as the global score) indicating worse sleep quality. Assessment of participants will be done after 6 weeks of intervention.	After 6 weeks of intervention
Pittsburgh Sleep Quality Index (PSQI)	Sleep is also an important determinant of health in general and specifically for stress. PSQI is a reliable self-reported questionnaire to examine the course and natural history of sleep over a 1-month time interval.89 Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Assessment of participants will be done after 12 weeks of intervention. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as the global score) indicating worse sleep quality.	After 12 weeks of intervention
Pittsburgh Sleep Quality Index (PSQI)	Sleep is also an important determinant of health in general and specifically for stress. PSQI is a reliable self-reported questionnaire to examine the course and natural history of sleep over a 1-month time interval.89 Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as the global score) indicating worse sleep quality. Assessment of participants will be done after 16 weeks of intervention.	After 16 weeks of intervention
Depression, Anxiety and Stress Scale -21 (DASS-21)	Depression, Anxiety and Stress Scale -21 (DASS-21) is an excellent self-reporting tool for measuring depression, anxiety, and stress features. DASS-21 is a modified version of the full test (DASS-42) with 7 items in each subscale. A baseline assessment of a participant will be done before the start of the intervention. The DASS-21 is the short form of the DASS-42, a self-report scale designed to measure the negative emotional states of depression, anxiety and stress.	Base line
Depression, Anxiety and Stress Scale -21 (DASS-21)	Depression, Anxiety and Stress Scale -21 (DASS-21) is an excellent self-reporting tool for measuring depression, anxiety, and stress features. DASS-21 is a modified version of the full test (DASS-42) with 7 items in each subscale. Assessment of participants will be done after 6 weeks of intervention.	After 6 weeks of intervention
Depression, Anxiety and Stress Scale -21 (DASS-21)	Depression, Anxiety and Stress Scale -21 (DASS-21) is an excellent self-reporting tool for measuring depression, anxiety, and stress features. DASS-21 is a modified version of the full test (DASS-42) with 7 items in each subscale. Assessment of participants will be done after 12 weeks of intervention.	After 12 weeks of intervention
Depression, Anxiety and Stress Scale -21 (DASS-21)	Depression, Anxiety and Stress Scale -21 (DASS-21) is an excellent self-reporting tool for measuring depression, anxiety, and stress features. DASS-21 is a modified version of the full test (DASS-42) with 7 items in each subscale. Assessment of participants will be done after 16 weeks of intervention.	After 16 weeks of intervention
International Physical Activity Questionnaire (IPAQ)	International Physical Activity Questionnaire (IPAQ) is the most widely used physical activity questionnaire. It measures the duration and frequency of physical activity in the last seven days in different domains. A baseline assessment of a participant will be done before the start of the intervention.	Base line
International Physical Activity Questionnaire (IPAQ)	International Physical Activity Questionnaire (IPAQ) is the most widely used physical activity questionnaire. It measures the duration and frequency of physical activity in the last seven days in different domains. Assessment of participants will be done after 6 weeks of intervention.	After 6 weeks of intervention
International Physical Activity Questionnaire (IPAQ)	International Physical Activity Questionnaire (IPAQ) is the most widely used physical activity questionnaire. It measures the duration and frequency of physical activity in the last seven days in different domains. Assessment of participants will be done after 12 weeks of intervention.	After 12 weeks of intervention
International Physical Activity Questionnaire (IPAQ)	International Physical Activity Questionnaire (IPAQ) is the most widely used physical activity questionnaire. It measures the duration and frequency of physical activity in the last seven days in different domains. Assessment of participants will be done after 16 weeks of intervention.	After 16 weeks of intervention
Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)	The Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A higher score on this tool means that respective parameters are on the worse side and lower scores mean respective parameters are on the better side. A baseline assessment of a participant will be done before the start of the intervention.	Base line
Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)	The Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A higher score on this tool means that respective parameters are on the worse side and lower scores mean respective parameters are on the better side. Assessment of participants will be done after 6 weeks of intervention.	After 6 weeks of intervention
Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)	The Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A higher score on this tool means that respective parameters are on the worse side and lower scores mean respective parameters are on the better side. Assessment of participants will be done after 12 weeks of intervention.	After 12 weeks of intervention
Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)	The Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A higher score on this tool means that respective parameters are on the worse side and lower scores mean respective parameters are on the better side. Assessment of participants will be done after 16 weeks of intervention.	After 16 weeks of intervention
Saliva Cortisol	Salivary cortisol reflects the amount of cortisol that escapes binding proteins and enters the tissues throughout the body, including the salivary glands and saliva. For saliva sampling, participants will be requested not to brush their teeth, floss, or eat and drink anything but water for 30 minutes prior to adequate saliva sampling for cortisol assessment. Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. A baseline assessment of a participant will be done before the start of the intervention.	At baseline
Saliva Cortisol	Salivary cortisol reflects the amount of cortisol that escapes binding proteins and enters the tissues throughout the body, including the salivary glands and saliva. For saliva sampling, participants will be requested not to brush their teeth, floss, or eat and drink anything but water for 30 minutes prior to adequate saliva sampling for cortisol assessment. Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be done after 12 weeks of intervention.	After 12 weeks of intervention
Saliva Cortisol	Salivary cortisol reflects the amount of cortisol that escapes binding proteins and enters the tissues throughout the body, including the salivary glands and saliva. For saliva sampling, participants will be requested not to brush their teeth, floss, or eat and drink anything but water for 30 minutes prior to adequate saliva sampling for cortisol assessment. Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be done after 16 weeks of intervention.	After 16 weeks of intervention
Blood Cortisol	Cortisol is a steroid hormone made by your adrenal glands. It helps your body respond to stress, regulate blood sugar, and fight infections. A blood sample is used to measure cortisol levels. The cortisol level may show problems with the adrenal glands or pituitary gland. Cortisol is made by the adrenal glands. A baseline assessment of a participant will be done before the start of the intervention.	At baseline
Blood Cortisol	Cortisol is a steroid hormone made by your adrenal glands. It helps your body respond to stress, regulate blood sugar, and fight infections. A blood sample is used to measure cortisol levels. The cortisol level may show problems with the adrenal glands or pituitary gland. Cortisol is made by the adrenal glands. Assessment of participants will be done after 12 weeks of intervention.	After 12 weeks of intervention
Blood Cortisol	Cortisol is a steroid hormone made by your adrenal glands. It helps your body respond to stress, regulate blood sugar, and fight infections. A blood sample is used to measure cortisol levels. The cortisol level may show problems with the adrenal glands or pituitary gland. Cortisol is made by the adrenal glands. Assessment of participants will be done after 16 weeks of intervention.	After 16 weeks of intervention
Hair Cortisol	Cortisol is a steroid hormone made by your adrenal glands. It helps your body respond to stress, regulate blood sugar, and fight infections. The cortisol level may show problems with the adrenal glands or pituitary gland. Cortisol is made by the adrenal glands. Assessment of participants will be done at the baseline of the study.	At baseline
Hair Cortisol	Cortisol is a steroid hormone made by your adrenal glands. It helps your body respond to stress, regulate blood sugar, and fight infections. The cortisol level may show problems with the adrenal glands or pituitary gland. Cortisol is made by the adrenal glands. Assessment of participants will be done after 12 weeks of intervention.	After 12 weeks of intervention
Smartphone Gait and Balance Application	The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done after 6 weeks.	After 6 weeks
Smartphone Gait and Balance Application	The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done after 12 weeks.	After 12 weeks
Smartphone Gait and Balance Application	The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task.Assessment will be done after 16 weeks.	After 16 weeks
T-Lymphocytes (CD3)	T-Lymphocytes (CD3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell and T helper cells. CD3 are immunoregulatory cells. The concentration of CD3 cells shows the status of the immune system.	Baseline
T-Lymphocytes (CD3)	T-Lymphocytes (CD3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell and T helper cells. CD3 are immunoregulatory cells. The concentration of CD3 cells shows the status of the immune system.	After 12 weeks
T-Lymphocytes (CD3)	T-Lymphocytes (CD3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell and T helper cells. CD3 are immunoregulatory cells. The concentration of CD3 cells shows the status of the immune system.	After 16 weeks
B-Lymphocytes (CD19)	B-Lymphocytes (CD19) are a biomarker for normal and neoplastic B cells, as well as follicular dendritic cells. CD19 functions as the dominant signalling component of a multimolecular complex on the surface of mature B cells. The concentration of CD19 cells shows the status of the immune system.	Baseline
B-Lymphocytes (CD19)	B-Lymphocytes (CD19) are a biomarker for normal and neoplastic B cells, as well as follicular dendritic cells. CD19 functions as the dominant signalling component of a multimolecular complex on the surface of mature B cells. The concentration of CD19 cells shows the status of the immune system.	After 12 weeks
B-Lymphocytes (CD19)	B-Lymphocytes (CD19) are a biomarker for normal and neoplastic B cells, as well as follicular dendritic cells. CD19 functions as the dominant signalling component of a multimolecular complex on the surface of mature B cells. The concentration of CD19 cells shows the status of the immune system.	After 16 weeks
T-Cell receptor CD4	CD4 (cluster of differentiation 4) is a glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). CD4 is found on the surface of immune cells such as T helper cells, monocytes, macrophages, and dendritic cells. The expression of CD4 cells shows the status of the immune system.	Baseline
T-Cell receptor CD4	CD4 (cluster of differentiation 4) is a glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). CD4 is found on the surface of immune cells such as T helper cells, monocytes, macrophages, and dendritic cells. The expression of CD4 cells shows the status of the immune system.	After 12 weeks
T-Cell receptor CD4	CD4 (cluster of differentiation 4) is a glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). CD4 is found on the surface of immune cells such as T helper cells, monocytes, macrophages, and dendritic cells. The expression of CD4 cells shows the status of the immune system.	After 16 weeks
T-Cell receptor CD8	CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). The CD8 co-receptor plays a role in T cell signalling and aiding with cytotoxic T cell-antigen interactions. The expression of CD8 cells shows the status of the immune system.	Baseline
T-Cell receptor CD8	CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). The CD8 co-receptor plays a role in T cell signalling and aiding with cytotoxic T cell-antigen interactions. The expression of CD8 cells shows the status of the immune system.	After 12 weeks
T-Cell receptor CD8	CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). The CD8 co-receptor plays a role in T cell signalling and aiding with cytotoxic T cell-antigen interactions. The expression of CD8 cells shows the status of the immune system.	After 16 weeks
Interleukin 6 (IL-6)	Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. The concentration of IL-6 shows the status of the inflammation in the body.	Baseline
Interleukin 6 (IL-6)	Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. The concentration of IL-6 shows the status of the inflammation in the body.	After 12 weeks
Interleukin 6 (IL-6)	Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. The concentration of IL-6 shows the status of the inflammation in the body.	After 16 weeks
Tumour Necrosis Factor alpha (TNF alpha)	Tumour Necrosis Factor-alpha (TNF alpha), is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation and is responsible for a diverse range of signalling events within cells, leading to necrosis or apoptosis. The concentration of TNF alpha shows the status of the inflammation in the body.	Baseline
Tumour Necrosis Factor alpha (TNF alpha)	Tumour Necrosis Factor-alpha (TNF alpha), is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation and is responsible for a diverse range of signalling events within cells, leading to necrosis or apoptosis. The concentration of TNF alpha shows the status of the inflammation in the body.	After 12 weeks
Tumour Necrosis Factor alpha (TNF alpha)	Tumour Necrosis Factor-alpha (TNF alpha), is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation and is responsible for a diverse range of signalling events within cells, leading to necrosis or apoptosis. The concentration of TNF alpha shows the status of the inflammation in the body.	After 16 weeks
C-reactive protein (CRP)	C-reactive protein is an annular pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells.	Baseline
C-reactive protein (CRP)	C-reactive protein is an annular pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells.	After 12 weeks
C-reactive protein (CRP)	C-reactive protein is an annular pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells.	After 16 weeks
Interferon-gamma (IFN-γ)	Interferon-gamma (IFN-γ) is a cytokine critical to both innate and adaptive immunity, and functions as the primary activator of macrophages, in addition to stimulating natural killer cells and neutrophils.	Baseline
Interferon-gamma (IFN-γ)	Interferon-gamma (IFN-γ) is a cytokine critical to both innate and adaptive immunity, and functions as the primary activator of macrophages, in addition to stimulating natural killer cells and neutrophils.	After 12 weeks
Interferon-gamma (IFN-γ)	Interferon-gamma (IFN-γ) is a cytokine critical to both innate and adaptive immunity, and functions as the primary activator of macrophages, in addition to stimulating natural killer cells and neutrophils.	After 16 weeks
Natural killer cells (CD56).	CD56 is a fundamental marker in the determination of human natural killer (NK) cell subsets. The degree of CD56 expression is ubiquitously used to define human NK cell maturation, functional, and tissue-specific subsets, yet a unifying implication for the degree of CD56 expression in NK cells remains elusive.	Baseline
Natural killer cells (CD56).	CD56 is a fundamental marker in the determination of human natural killer (NK) cell subsets. The degree of CD56 expression is ubiquitously used to define human NK cell maturation, functional, and tissue-specific subsets, yet a unifying implication for the degree of CD56 expression in NK cells remains elusive.	After 12 weeks
Natural killer cells (CD56).	CD56 is a fundamental marker in the determination of human natural killer (NK) cell subsets. The degree of CD56 expression is ubiquitously used to define human NK cell maturation, functional, and tissue-specific subsets, yet a unifying implication for the degree of CD56 expression in NK cells remains elusive.	After 16 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: IMRAN KHAN NIAZI, PhD, New Zealand College of Chiropractic

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Subclinical Spinal Pain
• Other Study ID Numbers: REC/01288 Imran Amjad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No