The Effects of Chiropractic Care and Children With Subclinical Spinal Pain

Not Applicable

Completed

• Conditions: Subclinical Spinal Pain
• Interventions: Other: Chiropractic care; Other: Control Group

• Registration Number: NCT05369143
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-11
• Study Start: 2022-05-30
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chiropractic care Group	Chiropractic care	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.
Control Group	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

Primary Outcome Measures

Name	Time	Method
Functional near-infrared spectroscopy (fNIRS)	After 16 weeks of intervention	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.
Whole head EEG(sub-cohort of participants)	After 16 weeks of intervention	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.
Heart rate variability	Up to 16 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Spatial working memory (SWM)	After 16 weeks of intervention	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.
Reaction time (RTI)	After 16 weeks of intervention	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.
Stockings of Cambridge (SoC)	After 16 weeks of intervention	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.
Delayed Matching to Sample (DMS)	After 16 weeks of intervention	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.
Paired Associate Learning (PAL)	After 16 weeks of intervention	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.
Health-related quality of life	After 16 weeks of intervention	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.

Trial Locations

Locations (1)

Mera Ghar Orphan House; 🇵🇰 Rawalpindi, Pakistan