The Effects of Chiropractic Care and Children With Subclinical Spinal Pain

NCT05369143 | Completed

• 1 other identifier: REC/01286 Imran Amjad
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Subclinical Spinal Pain

Outcome Measures

Primary Outcomes (9)

• 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 repeated after 6 weeks of intervention.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  After 16 weeks of intervention

Secondary Outcomes (24)

• Spatial working memory (SWM)

  Base line

• Spatial working memory (SWM)

  After 6 weeks of intervention

• Spatial working memory (SWM)

  After 12 weeks of intervention

• Spatial working memory (SWM)

  After 16 weeks of intervention

• Reaction time (RTI)

  Base line

Other Outcomes (14)

• Saliva Cortisol

  Base line

• Saliva Cortisol

  after 12 weeks of intervention

• Saliva Cortisol

  after 16 weeks of intervention

Study Arms (2)

Chiropractic care Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Chiropractic care OTHER

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.

Chiropractic care Group

Control Group OTHER

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

Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged between 10 and 18 years
• have subclinical spinal pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Mera Ghar Orphan House

Rawalpindi, Pakistan

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• IMRAN KHAN NIAZI, PhD

  New Zealand College of Chiropractic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 11, 2022
• Study Start: May 30, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)