Clinical trial NCT05369156: The Effects of Chiropractic Care in Adults With Subclinical Spinal Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subclinical Spinal Pain
Keywords: Subclinical Spinal Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: research
Primary purpose: TREATMENT

Brief summary: This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical pain.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: Base line
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 6 weeks
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 12 weeks of intervention
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: Aftwe 16 weeks of intervention
measure: Heart rate variability (HRV)
timeFrame: Up to 16 weeks
measure: Serum Brain-derived neurotrophic factor (BDNF)
timeFrame: Base line
measure: Serum Brain-derived neurotrophic factor (BDNF)
timeFrame: After 12 weeks of intervention
measure: Serum Brain-derived neurotrophic factor (BDNF)
timeFrame: After 16 weeks of intervention
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: 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
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: 16 weeks of intervention
measure: Stockings of Cambridge (SoC)
timeFrame: Base line
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: Base line.
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: Baseline
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: Immune Function Questionnaire (IFQ)
timeFrame: Base line
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: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Base line
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: After 6 weeks of intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: After 12 weeks of intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: After 16 weeks of intervention
measure: Depression, Anxiety and Stress Scale -21 (DASS-21)
timeFrame: Base line
measure: Depression, Anxiety and Stress Scale -21 (DASS-21)
timeFrame: After 6 weeks of intervention
measure: Depression, Anxiety and Stress Scale -21 (DASS-21)
timeFrame: After 12 weeks of intervention
measure: Depression, Anxiety and Stress Scale -21 (DASS-21)
timeFrame: After 16 weeks of intervention
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Base line
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: After 6 weeks of intervention
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: After 12 weeks of intervention
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: After 16 weeks of intervention
measure: Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)
timeFrame: Base line
measure: Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)
timeFrame: After 6 weeks of intervention
measure: Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)
timeFrame: After 12 weeks of intervention
measure: Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)
timeFrame: After 16 weeks of intervention
measure: Saliva Cortisol
timeFrame: At baseline
measure: Saliva Cortisol
timeFrame: After 12 weeks of intervention
measure: Saliva Cortisol
timeFrame: After 16 weeks of intervention
measure: Blood Cortisol
timeFrame: At baseline
measure: Blood Cortisol
timeFrame: After 12 weeks of intervention
measure: Blood Cortisol
timeFrame: After 16 weeks of intervention
measure: Hair Cortisol
timeFrame: At baseline
measure: Hair Cortisol
timeFrame: After 12 weeks of intervention
measure: Smartphone Gait and Balance Application
timeFrame: Baseline
measure: Smartphone Gait and Balance Application
timeFrame: After 6 weeks
measure: Smartphone Gait and Balance Application
timeFrame: After 12 weeks
measure: Smartphone Gait and Balance Application
timeFrame: After 16 weeks
measure: T-Lymphocytes (CD3)
timeFrame: Baseline
measure: T-Lymphocytes (CD3)
timeFrame: After 12 weeks
measure: T-Lymphocytes (CD3)
timeFrame: After 16 weeks
measure: B-Lymphocytes (CD19)
timeFrame: Baseline
measure: B-Lymphocytes (CD19)
timeFrame: After 12 weeks
measure: B-Lymphocytes (CD19)
timeFrame: After 16 weeks
measure: T-Cell receptor CD4
timeFrame: Baseline
measure: T-Cell receptor CD4
timeFrame: After 12 weeks
measure: T-Cell receptor CD4
timeFrame: After 16 weeks
measure: T-Cell receptor CD8
timeFrame: Baseline
measure: T-Cell receptor CD8
timeFrame: After 12 weeks
measure: T-Cell receptor CD8
timeFrame: After 16 weeks
measure: Interleukin 6 (IL-6)
timeFrame: Baseline
measure: Interleukin 6 (IL-6)
timeFrame: After 12 weeks
measure: Interleukin 6 (IL-6)
timeFrame: After 16 weeks
measure: Tumour Necrosis Factor alpha (TNF alpha)
timeFrame: Baseline
measure: Tumour Necrosis Factor alpha (TNF alpha)
timeFrame: After 12 weeks
measure: Tumour Necrosis Factor alpha (TNF alpha)
timeFrame: After 16 weeks
measure: C-reactive protein (CRP)
timeFrame: Baseline
measure: C-reactive protein (CRP)
timeFrame: After 12 weeks
measure: C-reactive protein (CRP)
timeFrame: After 16 weeks
measure: Interferon-gamma (IFN-γ)
timeFrame: Baseline
measure: Interferon-gamma (IFN-γ)
timeFrame: After 12 weeks
measure: Interferon-gamma (IFN-γ)
timeFrame: After 16 weeks
measure: Natural killer cells (CD56).
timeFrame: Baseline
measure: Natural killer cells (CD56).
timeFrame: After 12 weeks
measure: Natural killer cells (CD56).
timeFrame: After 16 weeks
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
Study officials:
affiliation: New Zealand College of Chiropractic
name: IMRAN KHAN NIAZI, PhD
role: PRINCIPAL_INVESTIGATOR
References: