Clinical trial NCT05369143: The Effects of Chiropractic Care and Children With Subclinical Spinal Pain
Official title: The Effects of Chiropractic Care on Neurophysiological Function Immune Markers and Health Related Quality of Life in Children With Subclinical Spinal Pain Using Artificial Intelligence Modelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subclinical Spinal Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 107
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* aged between 10 and 18 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
* have uncontrolled asthma
* nasal polyps
* use of an intranasal steroid spray one month or less before the study
* are HIV-positive
* are participating in another research study at the time of data collection
* have any diagnosed comorbidity or concomitant disease
* have allergies to yeast or yeast-derived products
* have chronic sinusitis or recent (within the last six weeks) episode of acute sinusitis.

Primary outcomes:
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: Base line
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 6 weeks of intervention
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 12 weeks of intervention and 16 weeks (4-week follow-up testing in a sub-group of participants. )
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 16 weeks of intervention
measure: Heart rate variability
timeFrame: Up to 16 Weeks
measure: Whole head EEG(sub-cohort of participants)
timeFrame: Base line
measure: Whole head EEG(sub-cohort of participants)
timeFrame: After 6 weeks of intervention
measure: Whole head EEG(sub-cohort of participants)
timeFrame: After 12 weeks of intervention
measure: Whole head EEG(sub-cohort of participants)
timeFrame: After 16 weeks of intervention
Secondary outcomes:
measure: Spatial working memory (SWM)
timeFrame: Base line
measure: Spatial working memory (SWM)
timeFrame: After 6 weeks of intervention
measure: Spatial working memory (SWM)
timeFrame: After 12 weeks of intervention
measure: Spatial working memory (SWM)
timeFrame: After 16 weeks of intervention
measure: Reaction time (RTI)
timeFrame: Base line
measure: Reaction time (RTI)
timeFrame: After 6 weeks of intervention
measure: Reaction time (RTI)
timeFrame: After 12 weeks of intervention
measure: Reaction time (RTI)
timeFrame: After 16 weeks of intervention
measure: Paired Associate Learning (PAL)
timeFrame: Base line
measure: Paired Associate Learning (PAL)
timeFrame: After 6 weeks of intervention
measure: Paired Associate Learning (PAL)
timeFrame: After 12 weeks of intervention
measure: Paired Associate Learning (PAL)
timeFrame: After 16 weeks of intervention
measure: Stockings of Cambridge (SoC)
timeFrame: At Baseline
measure: Stockings of Cambridge (SoC)
timeFrame: After 6 weeks of intervention
measure: Stockings of Cambridge (SoC)
timeFrame: After 12 weeks of intervention
measure: Stockings of Cambridge (SoC)
timeFrame: After 16 weeks of intervention
measure: Delayed Matching to Sample (DMS)
timeFrame: At Baseline
measure: Delayed Matching to Sample (DMS)
timeFrame: After 6 weeks of intervention
measure: Delayed Matching to Sample (DMS)
timeFrame: After 12 weeks of intervention
measure: Delayed Matching to Sample (DMS)
timeFrame: After 16 weeks of intervention
measure: Health-related quality of life
timeFrame: Base line
measure: Health-related quality of life
timeFrame: After 6 weeks of intervention
measure: Health-related quality of life
timeFrame: After 12 weeks of intervention
measure: Health-related quality of life
timeFrame: After 16 weeks of intervention
Other outcomes:
measure: Saliva Cortisol
timeFrame: Base line
measure: Saliva Cortisol
timeFrame: after 12 weeks of intervention
measure: Saliva Cortisol
timeFrame: after 16 weeks of intervention
measure: Hair Cortisol
timeFrame: Baseline
measure: Hair Cortisol
timeFrame: After 12 weeks of intervention
measure: Immune Function Questionnaire (IFQ)
timeFrame: At baseline
measure: Immune Function Questionnaire (IFQ)
timeFrame: After 6 weeks of intervention
measure: Immune Function Questionnaire (IFQ)
timeFrame: After 12 weeks of intervention
measure: Immune Function Questionnaire (IFQ)
timeFrame: After 16 weeks of intervention
measure: Inflammation markers from Fitbit data
timeFrame: Up to 16 Weeks
measure: Smartphone Gait and Balance Application
timeFrame: Baseline
measure: Smartphone Gait and Balance Application
timeFrame: After 6 weeks of intervention
measure: Smartphone Gait and Balance Application
timeFrame: After 12 weeks of intervention
measure: Smartphone Gait and Balance Application
timeFrame: After 16 weeks of intervention
Locations:
city: Rawalpindi
country: Pakistan
facility: Mera Ghar Orphan House
Study officials:
affiliation: New Zealand College of Chiropractic
name: IMRAN KHAN NIAZI, PhD
role: PRINCIPAL_INVESTIGATOR
References: